Tobacco UseNCT06105424
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
A study testing Lung Permeability Assessment in people with Tobacco Use and Smoking, run by RAI Services Company at 1 site in United States.
Trial summary
This will be a single-center, single-blind, four-cohort, 22-day ambulatory study during which up to 24 healthy adult subjects [6 smokers (SMK), 6 moist snuff consumers (MSC), 6 vapers (VAP), and 6 non-tobacco consumers (NTC)] will complete 3 measurements of lung permeability. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking, Smoking, Tobacco
- What is being tested?
- Lung Permeability Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2016to 28 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between the ages of 30 and 50 years, inclusive.
- Subjects met one (a, b, c, or d) of the following tobacco or non-tobacco use conditions based on self-report:
- SMK who exclusively smoked 10 - 20 combustible filtered cigarettes per day (CPD) 83 - 100 mm in length, non-menthol or menthol, for at least 3 years prior to Screening. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation were allowed at the discretion of the Investigator.
- MSC who exclusively consumed ≥ 1 can of moist snuff per week for at least 6 months prior to Screening. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation were allowed at the discretion of the Investigator.
- VAP who exclusively used a nicotine-containing "cig-a-like" and/or tank system daily for at least 3 months prior to Screening. Subjects reported using only products with the characterizing flavors of tobacco, menthol, or fruit (e.g., berry, strawberry, blueberry, banana). Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation were allowed at the discretion of the Investigator.
- NTC who had used no tobacco or nicotine-containing products for at least the past 5 years prior to Screening and did not plan to use any tobacco or nicotine containing products throughout the study.
Show all 28Show fewer
- Subjects met one (a, b, c, or d) of the following conditions:
- SMK had an ECO ≥ 15 ppm and ≤ 100 ppm and had a positive urine cotinine test (> 500 ng/mL).
- MSC had an ECO ≤ 5 ppm and had a positive urine cotinine test (> 500 ng/mL).
- VAP had an ECO ≤ 5 ppm and had a positive urine cotinine test (> 500 ng/mL).
- NTC had an ECO ≤ 5 ppm and had a negative urine cotinine test (≤ 200 ng/mL).
- Generally healthy (i.e., free of any acute or chronic health conditions in the opinion of the Investigator).
- Females had a negative serum pregnancy test result.
- Subjects were able to read, understand, and willing to sign an ICF and complete questionnaires written in English.
- Subjects were able to safely perform the required study procedures, as determined by the Investigator.
- Females of childbearing potential were willing to use a form of contraception acceptable to the Investigator for the timing as noted below through study discharge. Examples of acceptable forms of contraception included, but were not limited to, the following.
- Surgeries:
- Hysterectomy at least 6 months prior to Test Visit 1.
- Bilateral oophorectomy at least 6 months prior to Test Visit 1.
- Bilateral tubal ligation at least 6 months prior to Test Visit 1.
- Transcervical sterilization at least 6 months prior to Test Visit 1.
- Hormonal birth control at least 3 months prior to Test Visit 1.
- Non-hormonal intrauterine device (IUD) at least 3 months prior to Test Visit 1.
- Double barrier methods (e.g., condom and spermicide) at least 14 days prior to Test Visit 1.
- Abstinence at least 14 days prior to Test Visit 1.
- Vasectomized partner was acceptable birth control for females provided the surgery was performed at least 6 months prior to Test Visit 1.
- Postmenopausal at least 1 year prior to Test Visit 1 and confirmed by FSH > 40 mIU/mL.
- Non-vasectomized male subjects agreed to use a highly effective method of birth control (e.g., double-barrier method) with partners of childbearing potential and to not donate sperm during the study and for 90 days after the final administration of 99mTc-DTPA.
Who cannot join
- Subjects who met one of the following based upon their cohort:
- For SMK, use of any tobacco- or nicotine-containing products (e.g., e-cigs, moist snuff, chewing tobacco, nicotine replacement therapy (NRT), tobacco cigarettes that are heated but not burned, dissolvable nicotine products) other than combustible cigarettes within 30 days prior to Screening. NOTE: Subjects who smoked ≤ 6 cigars in the past 12 months prior to Screening were NOT excluded. Subjects who received short-term administration of or used a NRT as a temporary bridging treatment/aid were NOT excluded.
- For MSC, use of any tobacco- or nicotine-containing products (e.g., combustible or heated cigarettes, e-cigs, chewing tobacco, NRTs, dissolvable nicotine products) other than moist snuff within 30 days prior to Screening or regular exposure to cigarette smoke within 60 days prior to Screening (e.g., lived with a smoker who smoked in the home). NOTE: Subjects who received short-term administration of or used a NRT as a temporary bridging treatment/aid were NOT excluded.
- For VAP, use of any tobacco- or nicotine-containing products (e.g., combustible or heated cigarettes, moist snuff, chewing tobacco, NRTs, dissolvable nicotine products) other than nicotine-containing vaping products within 30 days prior to Screening or regular exposure to cigarette smoke within 60 days prior to Screening (e.g., lived with a smoker who smoked in the home). NOTE: Subjects who received short-term administration of or used a NRT as a temporary bridging treatment/aid were NOT excluded.
- For NTC, use of any tobacco- or nicotine-containing products (e.g., combustible or heated cigarettes, e-cigs, moist snuff, chewing tobacco, NRTs, dissolvable nicotine products) within 5 years prior to Screening or regular exposure to cigarette smoke within 60 days prior to Screening (e.g., lived with a smoker who smoked in the home).
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions, as determined by the Investigator, that precluded a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, or cardiac disease) based on safety assessments such as clinical laboratory tests, medical history, and physical/nasopharyngeal examinations.
Show all 26Show fewer
- History, presence, or clinical laboratory test results indicating diabetes.
- Presence of environmental allergies that result in allergic rhinitis which had been treated with any medication within 2 weeks of sample collection.
- Observed or report of a heavy cough that precluded a subject from successfully completing the lung permeability assessment.
- Use of any NRT or smoking cessation medication (e.g., nicotine gum, lozenge, or patch; varenicline [Chantix®], bupropion [Wellbutrin®, Zyban®]) within 30 days prior to Screening through completion of the study.
- A female who was pregnant, planned to become pregnant during the course of the study, or was breast feeding.
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- Post-bronchodilator FEV1:FVC ratio < 0.7 and FEV1 < 80% of predicted.
- Post-bronchodilator FEV1:FVC ratio < 0.75 and FEV1 increase ≥ 12% (or > 200 mL) from pre- to post-bronchodilator.
- Systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg.
- Fever (i.e., body temperature > 100.5°F).
- Body mass index (BMI) < 18.5 or > 40.0 kg/m2.
- Estimated creatinine clearance (by Cockcroft-Gault equation) < 80 mL/minute.
- Positive urine drug screen or alcohol test.
- Unwilling to follow study guidelines.
- Known history of any condition that may cause nose bleeds.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Postponing a decision to quit tobacco product use (defined as planning a quit attempt within 30 days of Screening) to participate in this study or previous attempt within 30 days prior to Screening.
- Participation in another clinical trial within 30 days prior to the first Test Visit. The 30 day window for each subject was derived from the date of the last study event in the previous study to the first Test Visit of the current study.
- Participation in another clinical trial in which a radiolabeled compound was administered within 1 year prior to the first Test Visit.
- Had received radiolabeled substances or had been exposed to radiation sources over the past 12 months or was likely to receive radiation exposure or radioisotopes within the next 12 months, such that participation in this study would increase the subject's total exposure beyond the recommended levels considered safe (i.e., weighted annual limit recommended by the International Commission on Radiological Protection of 3000 mrem).
Trial locations and contacts
1 site in 1 country.
About this study
This will be a single-center, single-blind, four-cohort, 22-day ambulatory study during which up to 24 healthy adult subjects [6 smokers (SMK), 6 moist snuff consumers (MSC), 6 vapers (VAP), and 6 non-tobacco consumers (NTC)] will complete 3 measurements of lung permeability. Nasal epithelial cells, sputum, and blood samples will also be collected for current and future biomarker research.
Read the detailed description
Test Visit 1 will consist of sampling for nasal epithelial cells, sputum, and blood. Additional subjects ("alternates") may be required to complete these procedures to better ensure that 24 subjects are available to complete the lung permeability assessments. During Test Visits 2, 3, and 4, subjects will provide additional blood samples and will complete the lung permeability procedure. A solution containing approximately 40 mCi of a radiolabeled tracer molecule (99mTc-DTPA) will be loaded into a radioaerosol administration system and subjects will breathe the aerosol over approximately 3 minutes, depositing approximately 1 mCi into the lungs (effective dose of approximately 0.3 rem). Subjects will lie supine in front of a gamma counter and a series of images will be obtained over 60 minutes, from which the 99mTc-DTPA clearance rate from the lungs will be calculated.
- Conditions
- Tobacco Use, Smoking, Smoking, Tobacco
- Being tested
- Lung Permeability Assessment
- Medical subject headings
- Tobacco Use, Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Permeability AssessmentProcedure or surgery
A gamma camera will be used to scintigraphically monitor the clearance of an inhaled radiolabeled tracer molecule from the lungs into the blood. Clearance will be monitored for 60 minutes. The rate of clearance of radioactivity will serve as an index of alveolar epithelial permeability.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Someone who exclusively smokes 10 - 20 combustible filtered cigarettes per day (CPD) 83 - 100 mm in length, non-menthol or menthol, for at least 3 years prior to Screening. Receives: Procedure: Lung Permeability Assessment |
| Moist Snuff Consumers | Experimental | Someone who exclusively consumes ≥ 1 can of moist snuff per week for at least 6 months prior to Screening. Receives: Procedure: Lung Permeability Assessment |
| Vapers | Experimental | Someone who exclusively uses a nicotine-containing "cig-a-like" and/or tank system daily for at least 3 months prior to Screening. Receives: Procedure: Lung Permeability Assessment |
| Non-Tobacco Consumers | Experimental | Someone who has used no tobacco or nicotine-containing products for at least the past 5 years prior to Screening and do not plan to use any tobacco or nicotine-containing products throughout the study. Receives: Procedure: Lung Permeability Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Permeability Feasibility
Assess the technical and logistical feasibility of conducting a clinical evaluation of lung permeability as a potential biomarker of effect of tobacco use.The outcome measure of this method development study: "the half-life (T 1/2) of inhaled 99mtechnetium diethylenetriaminepentaacetic acid (99mTC-DTPA) in lungs of study subjects by scintigraphy."
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start24 Sep 2016
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrudu Makena, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105424
- Sponsor's protocol ID
- BRP1602
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
- ClinicalTrials.gov ID
- NCT06105424
- Acronym / sponsor ID
- BRP1602
- Conditions
- Tobacco Use, Smoking, Smoking, Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2016 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, single-blind, four-cohort, 22-day ambulatory study during which up to 24 healthy adult subjects [6 smokers (SMK), 6 moist snuff consumers (MSC), 6 vapers (VAP), and 6 non-tobacco consumers (NTC)] will complete 3 measurements of lung permeability. Nasal epithelial cells, sputum, and blood samples will also be collected for current and future biomarker research.
Detailed description
Test Visit 1 will consist of sampling for nasal epithelial cells, sputum, and blood. Additional subjects ("alternates") may be required to complete these procedures to better ensure that 24 subjects are available to complete the lung permeability assessments. During Test Visits 2, 3, and 4, subjects will provide additional blood samples and will complete the lung permeability procedure. A solution containing approximately 40 mCi of a radiolabeled tracer molecule (99mTc-DTPA) will be loaded into a radioaerosol administration system and subjects will breathe the aerosol over approximately 3 minutes, depositing approximately 1 mCi into the lungs (effective dose of approximately 0.3 rem). Subjects will lie supine in front of a gamma counter and a series of images will be obtained over 60 minutes, from which the 99mTc-DTPA clearance rate from the lungs will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Procedure: Lung Permeability AssessmentSomeone who exclusively smokes 10 - 20 combustible filtered cigarettes per day (CPD) 83 - 100 mm in length, non-menthol or menthol, for at least 3 years prior to Screening. |
| Moist Snuff Consumers | Experimental | Procedure: Lung Permeability AssessmentSomeone who exclusively consumes ≥ 1 can of moist snuff per week for at least 6 months prior to Screening. |
| Vapers | Experimental | Procedure: Lung Permeability AssessmentSomeone who exclusively uses a nicotine-containing "cig-a-like" and/or tank system daily for at least 3 months prior to Screening. |
| Non-Tobacco Consumers | Experimental | Procedure: Lung Permeability AssessmentSomeone who has used no tobacco or nicotine-containing products for at least the past 5 years prior to Screening and do not plan to use any tobacco or nicotine-containing products throughout the study. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Males and females between the ages of 30 and 50 years, inclusive.
- Subjects met one (a, b, c, or d) of the following tobacco or non-tobacco use conditions based on self-report:
- Subjects met one (a, b, c, or d) of the following conditions:
- Generally healthy (i.e., free of any acute or chronic health conditions in the opinion of the Investigator).
- Females had a negative serum pregnancy test result.
Key exclusion criteria (26 listed)
- Subjects who met one of the following based upon their cohort:
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions, as determined by the Investigator, that precluded a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, or cardiac disease) based on safety assessments such as clinical laboratory tests, medical history, and physical/nasopharyngeal examinations.
- History, presence, or clinical laboratory test results indicating diabetes.
- Presence of environmental allergies that result in allergic rhinitis which had been treated with any medication within 2 weeks of sample collection.
- Observed or report of a heavy cough that precluded a subject from successfully completing the lung permeability assessment.
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 |
|---|---|---|
| Lung Permeability AssessmentA gamma camera will be used to scintigraphically monitor the clearance of an inhaled radiolabeled tracer molecule from the lungs into the blood. Clearance will be monitored for 60 minutes. The rate of clearance of radioactivity will serve as an index of alveolar epithelial permeability. | Procedure or surgery | Moist Snuff Consumers, Non-Tobacco Consumers, Smokers, Vapers |
Primary outcome
Lung Permeability Feasibility
Time frame: 60 minutes
Assess the technical and logistical feasibility of conducting a clinical evaluation of lung permeability as a potential biomarker of effect of tobacco use.The outcome measure of this method development study: "the half-life (T 1/2) of inhaled 99mtechnetium diethylenetriaminepentaacetic acid (99mTC-DTPA) in lungs of study subjects by scintigraphy."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
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
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.
Patrudu Makena, PhD study director
RAIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Permeability Assessment in people with Tobacco Use and Smoking, run by RAI Services Company at 1 site 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 28 inclusion and 26 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung Permeability Feasibility (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.