NCT03136120

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Ipratropium Bromide	Single dose of 500 mcg Ipratropium nebulizer solution will be administered to all subjects via inhalation route using nebulizer for 10 minutes. Ipratropium bromide is a clear, colorless nebulizer solution available in white plastic ampoules.
PROCEDURE	Flexible Bronchoscopy/Biopsy	After biopsy samples required for diagnosis have been collected, additional one to two TBCB samples will be taken for this study. 3-5 endobronchial biopsy samples will be taken from up to 5 subjects to compare drug distribution in proximal and distal lung.

Timeline

• Start date: 2017-11-21
• Primary completion: 2018-11-13
• Completion: 2018-11-13
• First posted: 2017-05-02
• Last updated: 2019-01-29

Locations

1 site across 1 country: United Kingdom