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

NCT06105424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-10-27

No results posted yet for this study

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

Interventions

PROCEDURE

Lung Permeability Assessment

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.

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Patrudu Makena, PhD · RAIS

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-24
Primary Completion
2016-12-28
Completion
2016-12-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105424 on ClinicalTrials.gov