NCT06105424

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-24
• Primary completion: 2016-12-28
• Completion: 2016-12-28
• First posted: 2023-10-27
• Last updated: 2023-10-27

Locations

1 site across 1 country: United States