Study to assess inhaled drug distribution in the lung
Research type
Research Study
Full 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
IRAS ID
211810
Contact name
Faron Jordan
Contact email
Sponsor organisation
GSK
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The purpose of this study is to evaluate the ability of inhaled drugs to reach certain regions of the lung by assessing lung biopsy samples taken by Trans-bronchial Cryo Biopsy (TBCB) procedure after patients have inhaled ipratropium bromide. TBCB is a relatively safe and minimally invasive procedure allowing the collection of lung biopsies.
Ipratropium bromide belongs to the group of medicines called bronchodilators which work by expanding the airways of the lung. Ipratropium bromide is widely used in treating lung conditions such as asthma or emphysema which are associated with wheezing and shortness of breath, and has a well-established safety record. In this study, ipratropium bromide will be used as an example of inhaled drug.
Interstitial Lung Diseases (ILDs), such as pulmonary fibrosis are a major cause of illness and death in the United Kingdom (UK). We are interested in understanding how well patients with ILDs can inhale medicines.
This study will recruit patients with suspected ILD who are referred for TBCB at
University College London Hospitals (UCLH) as part of their diagnostic tests. A few additional samples will be taken for this research only if safe to do so. One to three endobronchial forceps biopsy samples will be taken from up to 5 patients to allow comparison of drug distribution in the upper and lower lung.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/2009
Date of REC Opinion
27 Mar 2017
REC opinion
Further Information Favourable Opinion