The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping. An EMBARC2 and EMBARC3 Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Bronchiectasis is a complex heterogeneous disorder. Treatment is challenging and many recent randomized controlled trials have been negative. It is believed that bronchiectasis as a broad diagnosis incorporates multiple different patient subgroups (also known as phenotypes) and molecular entities (referred to as endotypes). This study aims to phenotype and endotype bronchiectasis during stable disease and exacerbations, to develop strategies for personalised medicine. Primary Objective To determine molecular endotypes of bronchiectasis which can guide response to treatment. Secondary Objectives 1. To determine molecular endotypes of stable bronchiectasis 2. To determine the causes and inflammatory profiles of bronchiectasis exacerbations 3. To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine 4. To perform in-vivo or in-vitro proof of concept studies using phenotypic data to identify patient populations likely to benefit in future randomized controlled trials This is an observational cohort study that will aim to identify patient subgroups and link these with meaningful clinical outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A previous CT scan showing bronchiectasis along with compatible clinical syndrome of cough, sputum production and/or recurrent respiratory tract infections.

• A primary diagnosis of bronchiectasis made by a respiratory physician

• At the screening visit the individual will have been clinically stable for 4 weeks indicated by the lack of any treatment with antibiotics or corticosteroids for a pulmonary exacerbation in the previous 4 weeks.

Locations
Other Locations
United Kingdom
University of Dundee
RECRUITING
Dundee
Contact Information
Primary
James D Chalmers, MD, PhD
james.chalmers@nhs.scot
01382660111
Backup
Amelia Shoemark, PhD
a.shoemark@dundee.ac.uk
01382660111
Time Frame
Start Date: 2019-11-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 1000
Treatments
Patients with bronchiectasis
Adult patients with bronchiectasis meeting the inclusion criteria.
Related Therapeutic Areas
Sponsors
Leads: University of Dundee

This content was sourced from clinicaltrials.gov