Validation Study to Compare Biomarkers of Fibrosis
Research type
Research Study
Full title
A Pilot Study to Compare Biomarkers of Fibrosis From Bronchoalveolar Lavage, Bronchial Brushing, and Bronchoabsorption in Healthy Subjects and Subjects with Idiopathic Pulmonary Fibrosis
IRAS ID
244119
Contact name
Samantha Howard
Contact email
Sponsor organisation
Indalo Therapeutics Inc.
Clinicaltrials.gov Identifier
REC, 18LO0556
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
The development of novel therapies for the treatment of IPF, an orphan disease, remains a great challenge despite the significant unmet medical need. Part of this challenge arises from the lack of available biomarkers that can be utilised as pharmacodynamic outcome measures in clinical studies of IPF; such biomarkers could greatly increase study efficiency and more rapidly advance drug development. Preliminary work has identified some biomarkers that are differentially expressed in patients with IPF compared to healthy subjects, while other potential biomarkers have not been well characterised.
The aim of this study is to compare biomarkers of fibrosis from bronchoalveolar lavage, bronchial brushing, bronchoabsorption, and blood samples from healthy subjects and subjects with IPF in order to identify differentially expressed biomarkers and to refine methods to analyse them. This will facilitate the design and conduct of a Phase I programme of a novel intervention for IPF that is being developed by Indalo Therapeutics, Inc.REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0556
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion