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

Smoking Clinical Trial

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

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06105424
Study type Interventional
Source RAI Services Company
Contact
Status Completed
Phase N/A
Start date September 24, 2016
Completion date December 28, 2016
View Details
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