BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability

NCT06105424 | Completed

• 1 other identifier: BRP1602
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. Nasal epithelial cells, sputum, and blood samples will also be collected for current and future biomarker research.

Conditions

Tobacco Use; Smoking; Smoking, Tobacco

Outcome Measures

Primary Outcomes (1)

• 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."

  60 minutes

Study Arms (4)

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.

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.

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.

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.

Procedure: Lung Permeability Assessment

Interventions

Lung Permeability Assessment PROCEDURE

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.

Moist Snuff Consumers; Non-Tobacco Consumers; Smokers; Vapers

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Patrudu Makena, PhD

  RAIS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: October 27, 2023
• Study Start: September 24, 2016
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: October 27, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)