Lung Diseases, Interstitial
Conditions
Keywords
Ipratropium bromide, Cryobiopsy, TBCB, IPF, Transbronchial cryobiopsy, Interstitial lung disease
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 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.
Interventions
DRUGIpratropium 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.
PROCEDUREFlexible 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.
Sponsors
University College London Hospitals
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 and above years of age inclusive, at the time of signing the informed consent. * Subjects with suspected ILD listed for TBCB for clinical reasons following review by the ILD services at University College London Hospitals (UCLH) in whom diagnosis has remained unclear following radiological and clinical assessment. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied, may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Male or Female. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the distribution of ipratropium bromide within the endobronchial sample | 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 | 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. |
Countries
United Kingdom
Outcome results
None listed