The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping

NCT03791086 | Recruiting

• 1 other identifier: 2017RC11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine molecular endotypes of stable bronchiectasis
2. 2.To determine the causes and inflammatory profiles of bronchiectasis exacerbations
3. 3.To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
4. 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

Conditions

Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

• Frequency of exacerbations

  Worsening of respiratory symptoms as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.

  up to 3 years

Secondary Outcomes (11)

• Time to first exacerbation

  3 years

• Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)

  3 years

• Quality of life- the St Georges Respiratory Questionnaire (SGRQ)

  3 years

• Quality of life- The Bronchiectasis impact measure (BIM)

  3 years

• Quality of life- The Bronchiectasis Health Questionnaire (BHQ)

  3 years

Study Arms (1)

Patients with bronchiectasis

Adult patients with bronchiectasis meeting the inclusion criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bronchiectasis

You may qualify if:

• 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.

You may not qualify if:

• Inability to give informed consent
• \<18years of age
• Patients with active tuberculosis
• Treatment with antibiotics or corticosteroids for a pulmonary exacerbation in the previous 4 weeks
• Bronchiectasis due to cystic fibrosis

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

University of Dundee

Dundee, DD1 9SY, United Kingdom

RECRUITING

Related Publications (1)

• Choi H, Hughes C, Eke Z, Shuttleworth M, Shteinberg M, Polverino E, Goeminne PC, Welte T, Blasi F, Shoemark A, Long MB, Aliberti S, Haworth CS, Ringshausen FC, Loebinger MR, Lorent N, Chalmers JD. Clinical Efficacy of Serum Antiglycopeptidolipid Core IgA Antibody Test for Screening Nontuberculous Mycobacterial Pulmonary Disease in Bronchiectasis: A European Multicenter Cohort Study. Chest. 2025 May;167(5):1300-1310. doi: 10.1016/j.chest.2024.10.029. Epub 2024 Oct 28.

  PMID: 39490969 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA Serum Sputum and sputum supernatant Urine Nasal swabs Nasal biopsy

Study Officials

• James D Chalmers, MD, PhD

  GSK/British Lung Foundation Chair of Respiratory Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James D Chalmers, MD, PhD

CONTACT

01382660111; james.chalmers@nhs.scot

Amelia Shoemark, PhD

CONTACT

01382660111; a.shoemark@dundee.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 2, 2019
• Study Start: November 1, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Available following the study subject to approval by the scientific committee as detailed at www.bronchiectasis.eu/dataaccess
• Access Criteria: Approval of an analysis protocol by an independent scientific committee

Locations

GB (1)