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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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 Cr

Brief 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 feasibility 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 subjects with suspected fibrotic ILD and requiring TBCB as part of their diagnostic assessment. 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples [ Time Frame: Up to Week 4 ]

Images and data will be generated using mass spectrometric techniques and histology to show the distribution of ipratropium bromide within the lung cryobiopsy samples taken from subjects with suspected Interstitial Lung disease.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of the distribution of ipratropium bromide within the endobronchial sample [ Time Frame: Up to Week 4 ]
    Images and data will be generated using mass spectrometric techniques and histology to show the distribution of ipratropium bromide within the endobronchial samples taken from subjects with suspected Interstitial Lung disease.
  • Distribution of ipratropium bromide in the proximal and distal lung [ Time Frame: Up to Week 4 ]
    1 to 3 endobronchial biopsy samples will be taken from up to 5 subjects to allow comparison of proximal and distal drug distribution.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: April 27, 2017
Date Started: July 3, 2017
Date Completion: April 3, 2018
Last Updated: April 27, 2017
Last Verified: April 2017