Tobacco UseNCT04800211

Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products

A study testing Experimental: Test Product 1 and Experimental: Test Product 2 in people with Tobacco Use, run by Altria Client Services LLC at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an e-vapor product (EVP) relative to adult smokers who continue smoking exclusively. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use
What is being tested?: Experimental: Test Product 1 and Experimental: Test Product 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 10 sitesUnited States
Study dates: 17 Jan 2017to 6 Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Study 1
Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
sign an IRB-approved informed consent form (ICF) for the study;
be between the ages of 30 and 65 years, inclusive, at the time of Screening, Visit 1;
have > 500 ng/ml urine cotinine measurement at Screening, Visit 1;
have smoked for ≥ 10 years and smoked an average of ≥ 10 manufactured cigarettes per day during the 12 months prior to Screening, Visit 1;

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Brief periods [i.e., up to 7 consecutive days] of non smoking during the 12 months prior to Screening, Visit 1 due to illness, trying to quit, or participation in a study where smoking was prohibited are acceptable.
indicate that he/she is "definitely" or "probably" willing and able to replace their cigarettes for 12 weeks with the assigned test e-Vapor product;
have daily access to text messaging capable cellular phone for daily product use reporting;
have a negative ethanol breath test and amphetamines, opiates, cannabinoids, and cocaine urine drug screen results at Screening, Visit 1;
Subjects with a prescription from a licensed physician will not be exempted from this criterion.
if female (all females), have a negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2 through Visit 7, inclusive;
if female, heterosexually active, and of childbearing potential (i.e., not surgically sterile or 2 years naturally postmenopausal), must have used a medically accepted method of contraception (listed below in a) and b)) prior to Screening, Visit 1 and must agree to continue to use such method(s) through the End of Study;
Surgically sterile includes bilateral tubal ligation, Essure, hysterectomy, or bilateral oophorectomy at least 6 months prior to Screening, Visit 1. Naturally postmenopausal is defined as women having 2 years without menses.
Acceptable methods of contraception are: hormonal (i.e., oral, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening, Visit 1; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Screening, Visit 1; and intrauterine device for at least 3 months prior to Screening, Visit 1; or only have a partner who has been vasectomized for at least 6 months prior to Screening, Visit 1.
Be willing and able to comply with the requirements of the study.
Study 2
Subjects must satisfy the following criteria before being enrolled into the study. Subject must:
have participated in and completed the 12-week ALCS-RA-16-06-EV study and have Baseline biomarker samples collected;
demonstrate willingness to participate by signing an Institutional Review Board (IRB)-approved ICF for the study;
have demonstrated consistent daily reporting of product use in the 12-week ALCS-RA-16-06-EV (≥ 80% reporting compliance);
if randomized to a Test group, have reported an average of no more than 10% of Baseline cigarette smoking per day through Week 11 of the 12-week ALCS-RA-16-06-EV study;
if randomized to a Test group, have reported use of at least two Test product cartridges per week in the 12-week ALCS-RA-16-06-EV study;
if randomized to a Test group, have exhaled carbon monoxide (eCO) measurements of ≤ 8 ppm at each post-Baseline time point in the 12-week ALCS-RA-16-06-EV study;
have daily access to text messaging capable cellular phone for daily product use reporting;
if female (all females), have a negative urine pregnancy test at Week 12 (Visit 1) through Week 24 (Visit 5), inclusive;
if female, heterosexually active, and of childbearing potential (i.e., not surgically sterile or 2 years naturally postmenopausal), must have used a medically accepted method of contraception (listed below in a) and b)) prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study and must agree to continue to use such method(s) through Week 24 (EOS);
Surgically sterile includes bilateral tubal ligation, Essure, hysterectomy, or bilateral oophorectomy at least 6 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study. Naturally postmenopausal is defined as women having 2 years without menses.
Acceptable methods of contraception are: hormonal (i.e., oral, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; and intrauterine device for at least 3 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; or only have a partner who has been vasectomized for at least 6 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study.
Be willing and able to comply with the requirements of the study.

Who cannot join

Study 1
Subjects may be excluded from the study if there is evidence of any of the following criteria. Exceptions may be permitted at the discretion of the Investigator and in consultation with the Sponsor or designee provided there would be no additional risk to the subject. Any exceptions will be documented.
History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes, existing respiratory diseases, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. (Note: chronic medical conditions controlled and on stable medications [over past 3 months] may not necessarily be exclusionary per Investigator discretion);
Currently taking medication for depression, asthma or diabetes;
Allergy to menthol;
Systolic blood pressure > 140 mmHg and / or diastolic blood pressure > 90 mmHg at Screening Visit 1.

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Have clinically significant abnormal findings on the physical examination, vital signs, electrocardiogram (ECG), or medical history that would jeopardize the safety of the subject, in the opinion of the Investigator;
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) at Screening, Visit 1;
Current evidence or any history of congestive heart failure;
Any acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks before Visit 3 (Day 1);
History of drug or alcohol abuse within 24 months of Visit 3 (Day 1) as defined by the Investigator;
BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening, Visit 1;
Post-bronchodilator Forced expiratory volume at one second (FEV1):Forced vital capacity (FVC) ratio < 0.7 and FEV1 < 50% of predicted at Screening, Visit 2;
Post-bronchodilator FEV1:FVC ratio < 0.75 and FEV1 increase ≥ 12% and > 200 mL from pre- to post-bronchodilator at Screening, Visit 2;
Estimated creatinine clearance (by Cockcroft-Gault equation) < 80 mL/min at Screening, Visit 1;
Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.5 times the upper limit of the reference range at Screening, Visit 1;
Female candidates who are pregnant, lactating, or intend to become pregnant from Screening, Visit 1 through End of Study;
Use of HDL-C raising medication / supplements (e.g., niacin, gemfibrizole, fenofibrate, etc.) within the past 3 months prior to Screening, Visit 1 or any time during the study;
Use of nicotine-containing products other than manufactured cigarettes (e.g., roll-your-own cigarettes, e-cigarette or e-Vapor products, Bidis, snuff, nicotine inhaler, pipe, cigar, smokeless tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Screening, Visit 1 through Visit 3 (Day 1) except as required for the purpose of this study;
Donation of blood or blood products, including plasma, history of significant blood loss in the opinion of the investigator, or receipt of whole blood or a blood product transfusion within 60 days prior to Visit 3 (Day 1);
Participation in a clinical study of an investigational drug, medical device, biologic, or of a tobacco product, within 30 days before Visit 3 (Day 1);
Participation in more than two ALCS studies within 12 months before Visit 3 (Day 1);
Already enrolled or failed screening for the current study at a different study site;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company.
Study 2
Subjects may be excluded from the study if there is evidence of any of the following. Exceptions may be permitted at the discretion of the Investigator and in consultation with the Sponsor or designee provided there would be no additional risk to the subject. Any exceptions will be documented.
Have clinically significant abnormal findings on the physical examination, vital signs, or ECG at the EOS visit (Visit 7) of the 12-week ALCS-RA-16-06-EV study that would jeopardize the safety of the subject, in the opinion of the Investigator;
Female subjects who are pregnant (as determined at the EOS visit [Visit 7] of the 12-week study), lactating, or intend to become pregnant from Visit 1 (Week 12) through Week 24 (EOS);
Use of any medication for depression, asthma, or diabetes at any time during the study;
Use of HDL-C raising medication / supplements (e.g., niacin, gemfibrozil, fenofibrate, etc.) at any time during the study;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of Celerion or any of the clinical study sites.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

LA Clinical Trials
Burbank, California, 91505
High Point Clinical Trials Center
High Point, North Carolina, 27265
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Clinical Research Consortium
Las Vegas, Nevada, 89119
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Celerion
Lincoln, Nebraska, 68502
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Rose Research Center, LLC
Raleigh, North Carolina, 27617
QPS Bio-Kinetic
Springfield, Missouri, 65802
Heartland Research Associates, LLC
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: An Open-Label, Parallel-Group, Controlled Study to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to Using e-Vapor Products for 24 Weeks

Read the detailed description

This study was conducted as a randomized, parallel-group, open-label, 24-week, controlled clinical study split into an initial 12-week study (Study 1), with a follow-up at 24 weeks (Study 2) in a sub-population of switchers. For Study 1 a total of 450 subjects were enrolled. Of those subjects who successfully completed Study 1, 150 were then enrolled into Study 2 with no interruption in study participation. The study compared changes in BoE and BoPH in AS who switched to ad libitum use of one of two test EVPs with those in the Control group who continued to smoke conventional cigarettes. The study enrolled AS who were considered to be in overall good health.

Conditions: Tobacco Use
Being tested: Experimental: Test Product 1, Experimental: Test Product 2
Medical subject headings: Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Test Product 1Other
Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Experimental: Test Product 2Other
Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)

Study groups in NCT04800211
Study group	Role	What they receive
Control	No intervention	Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Test 1	Experimental	Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation. *Product no longer sold commercially Receives: Other: Experimental: Test Product 1
Test 2	Experimental	Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation. *Product no longer sold commercially Receives: Other: Experimental: Test Product 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Urine Total NNAL (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of whole blood carboxyhemoglobin (COHb) (% Saturation) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood COHb (% Saturation) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of whole blood white blood cell (WBC) count (10^3 cells/uL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood WBC Count (10^3 cells/uL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of serum high density lipoprotein cholesterol (HDL-C) (mg/dL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of serum HDL-C (mg/dL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of plasma soluble Intercellular Adhesion Molecule-1 (sICAM-1) (ng/mL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Measured: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of plasma sICAM-1 (ng/mL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Measured: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood WBC Absolute Change From Baseline (10^3 Cells/uL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood WBC absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Serum HDL-C Absolute Change From Baseline (mg/dL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of serum HDL-C absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine 8-epi-prostaglandin F2alpha Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine 11-dehydrothromboxane B2 Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Plasma sICAM-1 Absolute Change From Baseline (ng/mL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of plasma sICAM-1 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine Total NNAL Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine total NNAL absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL)
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Whole Blood COHB Absolute Change From Baseline (% Saturation) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood COHB absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Measured: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization

Secondary outcomes (4)

Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Participant compliance for the abstention of any type of tobacco/nicotine product for the duration of the study was assessed by measuring the participant's exhaled carbon monoxide (eCO, ppm). According to their eCO measurements at Weeks 12 (study ALCS-RA-16-06-EV) and Week 24 (study ALCS-RA-17-11-EV), participants were categorized into 1 of 3 categories: 'eCO ≤ 5', 'eCO < 5 - ≤ 8', or 'eCO > 8'. Lower eCO values represent lower smoking exposure and increased compliance, with the 'eCO ≤ 5' category indicating that the participant abstained from smoking, the 'eCO < 5 - ≤ 8' category indicating low smoking exposure to the participant, and the 'eCO > 8' category indicating non-compliance with the study criteria that the participant refrain from smoking during the study.
Measured: Weeks 12 (Study ALCS-RA-16-06-EV) and Week 24 (Study ALCS-RA-17-11-EV) from randomization
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced expiratory volume in the first second (FEV1) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FEV1 = Forced Expiratory Volume in 1 Second
Measured: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced vital capacity (FVC) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FVC = Forced Vital Capacity
Measured: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted FEV1/FVC and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FEV1 = Forced Expiratory Volume in 1 Second, FVC = Forced Vital Capacity.
Measured: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 20176 Nov 2018

First posted16 Mar 2021
Study start17 Jan 2017
Primary completion20 Jul 2018
Study completion6 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This research study utilized a parallel-group, open-label, controlled design and was conducted at multiple study sites.
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04800211
Sponsor's protocol ID: ALCS-RA-16-06/ALCS-RA-17-11-EV
Status last verified: Feb 2025
First submitted: 11 Mar 2021
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco

All Tobacco Use trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Parallel-Group, Controlled Study to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to Using e-Vapor Products for 24 Weeks
ClinicalTrials.gov ID: NCT04800211
Acronym / sponsor ID: ALCS-RA-16-06/ALCS-RA-17-11-EV
Conditions: Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Altria Client Services LLCIndustry (pharma, biotech, devices)
Study start: 17 Jan 2017 (actual)
Primary completion: 20 Jul 2018 (actual)
Study completion: 6 Nov 2018 (actual)
First posted: 16 Mar 2021 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This research study utilized a parallel-group, open-label, controlled design and was conducted at multiple study sites.

Arm	Type	Receives
Control	No intervention	–Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Test 1	Experimental	Other: Experimental: Test Product 1Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation. *Product no longer sold commercially
Test 2	Experimental	Other: Experimental: Test Product 2Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation. *Product no longer sold commercially

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

Study 1
Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
sign an IRB-approved informed consent form (ICF) for the study;
be between the ages of 30 and 65 years, inclusive, at the time of Screening, Visit 1;
have > 500 ng/ml urine cotinine measurement at Screening, Visit 1;

Key exclusion criteria (32 listed)

Study 1
Subjects may be excluded from the study if there is evidence of any of the following criteria. Exceptions may be permitted at the discretion of the Investigator and in consultation with the Sponsor or designee provided there would be no additional risk to the subject. Any exceptions will be documented.
History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes, existing respiratory diseases, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. (Note: chronic medical conditions controlled and on stable medications [over past 3 months] may not necessarily be exclusionary per Investigator discretion);
Currently taking medication for depression, asthma or diabetes;
Allergy to menthol;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: Test Product 1Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)	Other	Test 1
Experimental: Test Product 2Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)	Other	Test 2

Primary outcome

Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Urine Total NNAL (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of whole blood carboxyhemoglobin (COHb) (% Saturation) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood COHb (% Saturation) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of whole blood white blood cell (WBC) count (10^3 cells/uL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood WBC Count (10^3 cells/uL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of serum high density lipoprotein cholesterol (HDL-C) (mg/dL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of serum HDL-C (mg/dL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of plasma soluble Intercellular Adhesion Molecule-1 (sICAM-1) (ng/mL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of plasma sICAM-1 (ng/mL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Summary of Whole Blood WBC Absolute Change From Baseline (10^3 Cells/uL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of whole blood WBC absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Serum HDL-C Absolute Change From Baseline (mg/dL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of serum HDL-C absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Urine 8-epi-prostaglandin F2alpha Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of urine 8-epi-prostaglandin F2alpha absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Urine 11-dehydrothromboxane B2 Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of urine 11-dehydrothromboxane B2 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Plasma sICAM-1 Absolute Change From Baseline (ng/mL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of plasma sICAM-1 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Urine Total NNAL Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of urine total NNAL absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Summary of Whole Blood COHB Absolute Change From Baseline (% Saturation) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Time frame: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of whole blood COHB absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3

4 secondary outcomes

Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Time frame: Weeks 12 (Study ALCS-RA-16-06-EV) and Week 24 (Study ALCS-RA-17-11-EV) from randomization
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Time frame: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Time frame: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Time frame: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test 1	151	121
Test 2	150	125
Control	149	136

Primary outcome: Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]

Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12. Mean (Standard Deviation). Unit: ng/g

Measure	Test 1 n = 127	Test 2 n = 131	Test 1 + Test 2 Group n = 258	Control n = 138
Visit 3 (Baseline): Week 1	309.098 (253.5221)	294.831 (212.1778)	301.854 (233.0988)	311.851 (245.2203)
Visit 5: Week 6	127.254 (191.0786)	120.568 (157.7745)	123.925 (174.9627)	308.521 (220.7403)
Visit 7: Week 12	101.544 (146.4668)	124.000 (163.0721)	113.159 (155.3513)	300.819 (217.6292)
Change from Baseline (Week 6)	-180.390 (206.3278)	-173.299 (186.8030)	-176.859 (196.4791)	-8.733 (140.9375)
Change from Baseline (Week 12)	-191.327 (220.6982)	-160.201 (192.1456)	-175.228 (206.5607)	-15.898 (149.1447)

Test 1: Mean Difference (Net): -178.789 (95% CI -204.899 to -152.678), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -184.391 (95% CI -211.184 to -157.598), p <.0001, Mixed Models Analysis
Test 2: Mean Difference (Net): -175.100 (95% CI -200.964 to -149.237), p <.0001, Mixed Models Analysis

Population analysed: Modified Intention-to-Treat (mITT): All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.

Primary outcome: Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]

Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]. Mean (Standard Deviation). Unit: ng/g

Measure	Test 1 n = 47	Test 2 n = 50	Test 1 + Test 2 Group n = 97	Control n = 49
Baseline: Week 1	258.644 (190.1771)	294.309 (217.0554)	277.028 (204.2020)	368.502 (255.5299)
Visit 1: Week 12	37.240 (74.0723)	65.631 (105.4324)	51.875 (92.2293)	357.472 (261.5709)
Visit 3: Week 18	34.715 (73.2359)	56.986 (110.8673)	46.863 (95.7548)	294.906 (194.0554)
Visit 5: Week 24	40.991 (80.9328)	80.808 (174.5894)	62.227 (139.6906)	274.912 (186.7002)
Change from Baseline (Week 12)	-221.403 (177.5875)	-228.678 (187.6797)	-225.153 (181.9443)	-11.030 (130.5603)
Change from Baseline (Week 18)	-222.851 (172.2263)	-234.967 (198.3954)	-229.460 (186.0037)	-78.423 (149.1454)
Change from Baseline (Week 24)	-218.417 (171.7527)	-215.432 (213.0743)	-216.825 (193.8228)	-85.075 (134.0116)

Test 1: Mean Difference (Net): -248.311 (95% CI -286.423 to -210.199), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -247.572 (95% CI -280.904 to -214.241), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -245.868 (95% CI -284.945 to -206.791), p <.0001, Mixed Models Analysis

Population analysed: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.

Primary outcome: Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]

Time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12. Mean (Standard Deviation). Unit: percent saturation

Measure	Test 1 n = 127	Test 2 n = 131	Test 1 + Test 2 Group n = 258	Control n = 138
Visit 3 (Baseline): Week 1	5.63 (2.073)	5.39 (1.868)	5.51 (1.971)	5.61 (1.957)
Visit 5: Week 6	3.26 (1.790)	3.10 (1.449)	3.18 (1.626)	6.05 (2.029)
Visit 7: Week 12	2.99 (1.550)	2.92 (1.141)	2.95 (1.351)	5.68 (1.986)
Change from Baseline (Week 6)	-2.34 (2.278)	-2.30 (2.355)	-2.32 (2.313)	0.40 (1.813)
Change from Baseline (Week 12)	-2.49 (2.498)	-2.44 (2.187)	-2.46 (2.337)	0.07 (1.920)

Test 1: Mean Difference (Net): -2.287 (95% CI -2.582 to -1.992), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -2.415 (95% CI -2.722 to -2.107), p <.0001, Mixed Models Analysis
Test 2: Mean Difference (Net): -2.382 (95% CI -2.673 to -2.090), p <.0001, Mixed Models Analysis

Primary outcome: Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]

Time frame: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]. Mean (Standard Deviation). Unit: percent saturation

Measure	Test 1 n = 47	Test 2 n = 50	Test 1 + Test 2 Group n = 97	Control n = 48
Baseline: Week 1	5.36 (2.096)	5.27 (1.572)	5.31 (1.835)	5.60 (1.607)
Visit 1: Week 12	2.28 (0.786)	2.52 (0.796)	2.40 (0.796)	6.34 (2.052)
Visit 3: Week 18	2.61 (0.759)	2.92 (0.944)	2.78 (0.876)	6.74 (1.971)
Visit 5: Week 24	2.17 (0.635)	2.34 (0.940)	2.26 (0.813)	5.59 (1.460)
Change from Baseline (Week 12)	-3.08 (2.252)	-2.75 (1.863)	-2.91 (2.057)	0.75 (2.019)
Change from Baseline (Week 18)	-2.65 (1.940)	-2.33 (1.994)	-2.47 (1.966)	1.18 (1.894)
Change from Baseline (Week 24)	-3.13 (1.947)	-2.89 (1.941)	-3.00 (1.937)	0.04 (1.511)

Test 1: Mean Difference (Net): -3.106 (95% CI -3.502 to -2.710), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -2.824 (95% CI -3.235 to -2.414), p <.0001, Mixed Models Analysis
Test 1: Mean Difference (Net): -3.228 (95% CI -3.553 to -2.904), p <.0001, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1 (ALCS-RA-16-06-EV)	1 of 151 (0.7%)	49 of 151 (32.5%)	0 of 151
Test 2 (ALCS-RA-16-06-EV)	1 of 150 (0.7%)	47 of 150 (31.3%)	0 of 150
Control (ALCS-RA-16-06-EV)	1 of 149 (0.7%)	24 of 149 (16.1%)	0 of 149
Overall (ALCS-RA-16-06-EV)	3 of 450 (0.7%)	120 of 450 (26.7%)	0 of 450
Test 1 (ALCS-RA-17-11-EV)	0 of 48 (0%)	13 of 48 (27.1%)	0 of 48
Test 2 (ALCS-RA-17-11-EV)	0 of 50 (0%)	15 of 50 (30%)	0 of 50
Control (ALCS-RA-17-11-EV)	0 of 52 (0%)	10 of 52 (19.2%)	0 of 52
Overall (ALCS-RA-17-11-EV)	0 of 150 (0%)	38 of 150 (25.3%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery Edmiston, PhD study director

Altria Client Services

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Test Product 1 and Experimental: Test Product 2 in people with Tobacco Use, run by Altria Client Services LLC at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV] (time frame: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04800211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.