AzTrials
AzTrials

COPDNCT07108166

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

A study testing Cigarette and THS in people with COPD and Smoking, run by Philip Morris Products S.A. at 112 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test [6MWT]) after switching… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD, Smoking, Tobacco Use
What is being tested?
Cigarette and THS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
112 sitesin 9 countries
Study dates
2 Apr 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult, both sexes, aged ≥ 40 years.
  • Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.
  • Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or > 40 kg (female). Checked at V1 and V2.
  • Patient has a CIG smoking history ≥ 10 years.
  • Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2.
  • Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2.
Show all 9Show fewer
  • Patient agrees to be randomized into one of the two study arms. Checked at V2.
  • Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC <70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 < 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for > three months a year for the two consecutive years prior to the screening visit). Checked at V2.
  • Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.)

Who cannot join

  • Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
  • Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.
  • Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.
  • Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.
  • Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2.
  • Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read).
Show all 18Show fewer
  • Patient with a history of asthma.
  • Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).
  • Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.
  • Patient with active or history of alcohol and/or drug abuse within the past year.
  • Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C).
  • Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.
  • Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion.
  • Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.
  • Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2.
  • Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.
  • Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2.
  • Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.

Trial locations and contacts

112 sites in 9 countries.

112 sites in 9 countries

United States46 sites

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Florida International Medical Research

    Coral Gables, Florida, 33134

  • Alfa Medical Research

    Davie, Florida, 33024

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020

  • D&H Doral Research Center

    Doral, Florida, 33122

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • Felicidad Med Research

    Hialeah, Florida, 33012

  • New Life Medical Research Center, Inc

    Hialeah, Florida, 33012

  • The Medici Medical Research, LLC

    Hollywood, Florida, 33021

  • HDH Research Inc

    Houston, Texas, 77022

  • Prolato Research LLC.

    Houston, Texas, 77054

  • Houston Pulmonary Medicine Associates

    Houston, Texas, 77089

  • Pioneer Research Solutions Inc

    Houston, Texas, 77099

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77338

  • D&H Pompano Research Center

    Margate, Florida, 33063

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069

  • Med-Care Research Corp

    Miami, Florida, 33125

  • EMDA Clincal Research

    Miami, Florida, 33126

  • Sones Medical Research

    Miami, Florida, 33133

  • Suncoast Research Group, LLC dba Flourish Research

    Miami, Florida, 33135

  • Melgar-Caro Medcenter and Community Research

    Miami, Florida, 33145

  • D&H National Research Center- Miami

    Miami, Florida, 33155.0

  • Biomed Research & Medical Center.Llc

    Miami, Florida, 33156

  • Global Health Clinical Trials Corp.

    Miami, Florida, 33165

  • Professional Research Center Inc

    Miami, Florida, 33172

  • Newgen Health Group

    Miami, Florida, 33176

  • Reserka LLC

    Miami, Florida, 33176

  • Pharma Medical Innovations

    Miami Lakes, Florida, 33014

  • San Marcus Research

    Miami Lakes, Florida, 33015

  • MedQuest Translational Sciences LLC

    Miami Lakes, Florida, 33016.0

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32803

  • LinQ Research, LLC

    Pearland, Texas, 77584

  • Comprehensive Medical & Research Center

    Plantation, Florida, 33317

  • CDC Research Institute

    Port Saint Lucie, Florida, 34952

  • Treasure Coast Medical Research Group

    Port Saint Lucie, Florida, 34986

  • Element Research Group

    San Antonio, Texas, 78258

  • Medrasa Clinical Research

    Sherman, Texas, 75092

  • Advanced Research Institute, Inc

    St. Petersburg, Florida, 33710

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038

  • D&H Tamarac Research Center

    Tamarac, Florida, 33321

  • Metropolitan Clinical Research Center

    Tamarac, Florida, 33321

  • Optimum Clinical Trial Group

    Tampa, Florida, 33612

  • Guardian Angel

    Tampa, Florida, 33614

Other trials in United States

Germany14 sites

  • Klinische Forschung Berlin Mitte /Pratia Germany

    Berlin, 10117

  • Research Center for Medical Studies

    Berlin, 10717

  • Klifeck GmbH

    Delitzsch, 4509

  • Klinische Forschung Hannover-Mitte GmbH /Pratia Germany

    Hanover, 30159

  • Klinische Forschung Karlsruhe GmbH / Pratio Germany

    Karlsruhe, 76137

  • Facharzt für Innere Medizin und Pneumologie

    Leipzig, 04157

  • POIS Sachsen GmbH

    Leipzig, 4509

  • Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH

    Neu-Isenburg, 63263

  • FutureMeds Frankfurt

    Offenbach, 63065

  • Praxis Reinfeld Mitte

    Reinfeld, 23858

  • Siteworks - Prüfzentrum Schleswig | RespiRatio

    Schleswig, 24837

  • BAG Peter Fried / Dr. med. Roman Rubin

    Wiesbaden, 65183

  • Velocity Clinical Research Wiesbaden

    Wiesbaden, 65189

  • Lungenpraxis Witten

    Witten, 58452

Other trials in Germany

United Kingdom10 sites

  • Panthera Biopartners

    Enfield, EN3 4GS

  • Panthera Biopartners

    Glasgow, G51 4TF

  • Velocity High Wycombe

    High Wycombe, HP11 2QW

  • 4 Medical Clinical Solutions (4MCS)

    London, IG1 4HP

  • 4 Medical Clinical Solutions (4MCS)

    Manchester, M27 8FF

  • FutureMeds Liverpool

    Metropolitan Borough of Wirral, CH62 6EE

  • Panthera Biopartners

    Preston, PR2 9QB

  • Panthera Biopartners

    Rochdale, OL11 4AU

  • Panthera Biopartners

    Sheffield, S2 5FX

  • Panthera Biopartners

    York, YO24 4LJ

Other trials in United Kingdom

Japan9 sites

  • Soejima Clinic

    Fukuoka, 812-0016

  • Maebashi North Hospital

    Gunma, 371-0054

  • Akashi Medical Center

    Hyōgo, 674-0063

  • Fukuwa Clinic

    Tokyo, 104-0031

  • Kouwa Clinic

    Tokyo, 170-0003

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

  • Sanyuudo Hospital

    Yamagata, 992-0045

  • Yokohama Minoru Clinic

    Yokohama, 232-0064

  • Clinical Research Hospital Tokyo

    Yotsuya, 160-0004

Other trials in Japan

Poland9 sites

  • Centrum Medycyny Oddechowej Mroz Spolka jawna

    Bialystok, 15-044

  • BioResearch Group Sp. z.o.o

    Kajetany, 05-830

  • FutureMeds Krakowskie Centrum Medyczne

    Krakow, 31-501

  • FutureMeds Łódź

    Lodz, 91-363

  • RCMed Oddział Sochaczew

    Sochaczew, 96-500

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215

  • FutureMeds Targówek

    Warsaw, 03-291

  • Dobrostan

    Wroclaw, 53-301

  • FutureMeds Wrocław

    Wroclaw, 53-673

Other trials in Poland

Romania7 sites

  • Ames Research Center

    Bragadiru, 077025

  • Sc. Centrul Medical Sana Srl

    Brasov, 500440

  • Sana Medical Center

    Bucharest, 11025

  • Ames Research Center

    Calarasi, 910103

  • Clintrial Medical Centre SRL

    Dobrosloveni, 237143

  • Spital de Pneumologie dr Lavinia Davidescu Oradea

    Oradea, 410163

  • AI Clinical Research

    Sibiu, 550082

Other trials in Romania

Bulgaria6 sites

  • MHAT Rahila Angelova

    Pernik, 2300

  • MHAT Lyulin EAD

    Sofia, 1336

  • Medical Center Hera EOOD

    Sofia, 1510

  • Medical Center Pulmovision Ltd

    Sofia, 1756

  • SHATPD Dr. Treyman

    Veliko Tarnovo, 5003

  • SHATPPD Vratsa

    Vratsa, 3000

Other trials in Bulgaria

Czechia6 sites

  • MUDr. Otakar Hokynar - plicni ambulance

    Kralupy nad Vltavou, 278 01

  • Ordinace pro tbc a respirační nemoci s.r.o.

    Olomouc, 779 00

  • CCR Ostrava s.r.o.

    Ostrava, 702 00

  • Medicon a.s.

    Prague, 140 00

  • Prvni plicni ambulance s.r.o.

    Prague, 190 00

  • Pneumologie Varnsdorf s.r.o.

    Varnsdorf, 407 47

Other trials in Czechia

Slovakia5 sites

  • PANACEUM s.r.o.

    Košice, 040 01

  • Vseobecna ambulancia pre dospelych

    Košice, 040 01

  • Pulmo s.r.o.,

    Prešov, 080 01

  • Plucna ambulancia Hrebenar S.R.O.

    Spišská Nová Ves, 5201

  • Alergia s. r. o.

    Topoľčany, 955 01

Other trials in Slovakia

About this study

Official title: A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test [6MWT]) after switching to THS compared to continuing to smoking cigarettes.

Being tested
Cigarette, THS
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Smoking, Tobacco Use

What participants receive

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

  • CigaretteOther

    COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.

  • THSOther

    COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.

Study groups in NCT07108166
Study groupRoleWhat they receive
CigaretteActive comparatorNot described
Receives: Other: Cigarette
THSActive comparatorNot described
Receives: Other: THS

What is being measured

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

  1. Reduction in 24-hour cough frequency

    To demonstrate a change in 24-hour cough frequency in COPD patients with chronic bronchitis switching from cigarette (CIG) to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to end of week 24 (end of the exposure period).

Secondary outcomes (13)

  1. Changes in lung function (from Baseline in FEV1 post-bronchodilator)

    To describe changes from Baseline in FEV1 post-bronchodilator in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to end of week 24 (end of the exposure period).

  2. Changes in the 24-hour cough frequency over time

    To describe changes in the 24-hour cough frequency over time in in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12.

  3. Percentage of patients with a change in 24-hour cough frequency over time

    To describe the percentage of patients with a change in 24-hour cough frequency over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24

  4. Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough

    To describe changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. It consists of 28 items to which the patient responds on a 4-point Likert scale, ranging from 1=strongly disagree, to 4=strongly agree. The total score is the sum of all individual items. Lower scores indicate a better outcome.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

  5. Changes in cough severity over time

    To describe changes in cough severity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

  6. Changes in bronchial hyperresponsiveness (BHR) mannitol test over time

    To describe changes in bronchial hyperresponsiveness (BHR) mannitol test over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG, at sites with full testing capabilities for BHR testing.

    Measured: Measured from start of product use to end of week 24 (end of the exposure period).

  7. Impact of COPD (cough, sputum, dyspnea, chest tightness) on health status

    To assess the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status in COPD by the COPD Assessment Test (CAT) over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    The CAT questionnaire consists of eight items, each answered on a semantic six-point differential scale from 0 to 5. The CAT score is calculated as the sum of the responses. Scores range from 0 to 40 with higher scores representing worse health outcomes.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

  8. Changes in shortness of breath assessed over time

    To describe changes in shortness of breath assessed over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to end of week 24 (end of the exposure period).

  9. Changes in functional capacity over time

    To describe changes in functional capacity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 12 and 24.

  10. Changes in exposure to carbon monoxide over time

    Change from Baseline in carbon monoxide (CO) exposure levels measured from venous blood carboxyhemoglobin (COHb) at the end of weeks 1, 4, 12, and 24.

    Measured: Measured from start of product use to end of week 24 (end of the exposure period).

  11. Changes in self-reported tobacco and nicotine containing product consumption

    Changes from Baseline in self-reported tobacco and nicotine containing product consumption and change in self-reported CIG and overall tobacco consumption evaluated with the ABOUT Tobacco exposure Tool (ABOUT-TeT). This instrument is a questionnaire to record self-reported consumption of tobacco and nicotine containing products. Patients will be asked to self-report the number of CIG, THS Induction Sticks, and other tobacco and nicotine containing products used on average per day over the last week. Patients will complete the questionnaire every seven days, from week 1 to week 24.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

  12. Changes in nicotine exposure levels

    Change from Baseline in nicotine exposure levels in spot urine adjusted to creatinine (Nicotine equivalents [NEQ]).

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

  13. Changes in acrylonitrile exposure levels

    Change from Baseline in acrylonitrile exposure levels in 2-Cyanoethyl Mercapturic Acid N-Acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) measured in urine and expressed as concentration adjusted to creatinine.

    Measured: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

Timeline

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

  1. First posted6 Aug 2025
  2. Study start2 Apr 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108166
Sponsor's protocol ID
P1-FAF-16
Status last verified
Aug 2026
First submitted
22 May 2025
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cigarette and THS in people with COPD and Smoking, run by Philip Morris Products S.A. at 112 sites in 9 countries.

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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Germany, United Kingdom, Japan, Poland and 4 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Reduction in 24-hour cough frequency (time frame: Measured from start of product use to end of week 24 (end of the exposure period).). 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 NCT07108166.

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 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in