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Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease

Lung Diseases, Interstitial Clinical Trial

Official title:
Study to Assess Inhaled Drug Distribution in the Distal Lung and Interstitium Using Cryobiopsy Samples From Subjects With Suspected Interstitial Lung Disease Undergoing Cryobiopsy for Clinical Reasons

Clinical Trial Summary

Interstitial lung disease (ILD) often affects distal lung, and the evaluation of drug distribution to the relevant lung compartments is essential for development of new treatment options. This single center study will utilize samples obtained by transbronchial cryobiopsy (TBCB) procedure to assess the distribution of inhaled drugs in the lungs of the subjects with fibrotic lung disease using mass spectrometry techniques. The study will have a single visit and will include approximately 20 adult subjects with suspected fibrotic ILD and requiring TBCB as part of their diagnostic assessment. This will provide TBCB samples from up to 20 subjects, up to 5 of whom may also provide endobronchial forceps biopsy samples. The study will have 3 phases including screening to check the eligibility, biopsy phase in which all subjects will receive nebulized ipratropium bromide 500 microgram (mcg) for 10 minutes immediately before undergoing bronchoscopy and follow up phase from 7 to 14 days after the procedure. Drug distribution in the lung will be assessed by analyzing biopsy samples collected using mass spectrometry and imaging techniques.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03136120
Study type Observational
Source GlaxoSmithKline
Contact
Status Completed
Phase
Start date November 21, 2017
Completion date November 13, 2018
View Details
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