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

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Brief Title

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

Official Title

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

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. 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.
    

Detailed Description

      Background: Bronchiectasis is a common disabling and heterogeneous disease that has been
      neglected in terms of basic and clinical research. Recent controlled trials have failed to
      achieve their primary end-points, likely because the optimal patient population to benefit
      from antibiotic, mucoactive and anti-inflammatory drugs has not been identified. This study
      aims to explore the clinical, microbiological, inflammatory and functional heterogeneity of
      the disease with the aim of identifying patient endotypes for stratified medicine.

      Study aims and objectives

        1. To determine the molecular endotypes of bronchiectasis during stable disease

        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
           Study Design: Observational Cohort study

      Study methods:

      Patients with bronchiectasis will be recruited into an observational study, the objectives of
      which will be to:

      Aim 1 will define and validate endotypes of stable bronchiectasis by studying up to 1000
      patients with bronchiectasis. Clinical data, sputum microbiome, sputum proteomics, and
      systemic and sputum inflammatory marker measurement will be incorporated for analysis. A
      sub-study (n=200) will be performed using air liquid interface culture of primary airway
      epithelial cells. Patients will have brushings of the inferior nasal turbinate with
      assessment of % ciliation, ciliary beat frequency and pattern by high speed video microscopy
      before and after culture.

      Aim 2 will replicate the phenotyping approach to stable patients with 160 patients during
      exacerbation. This will identify changes from baseline in microbiota, proteomic and other
      markers associated with onset of exacerbation and allow classification of clusters of
      exacerbation.

      Aim 3, we will externally validate candidate phenotype/endotypes in registered ethically
      approved external biobanks and aim to demonstrate that validated markers to be linked to
      potential treatment responses for use in stratified medicine trials.

      In total we will recruit 1000 patients for study. These patients will attend the Clinical
      Research Centre at one of the participating study centres at least once and undergo sampling
      along with collecting of clinical data. Patients will be asked to consent for their samples
      to be linked to data held on the EMBARC registry.

      Nature of outputs and outcomes/results expected:

      This study will aim to establish detailed endotypes in bronchiectasis which can guide
      response to treatment.
    


Study Type

Observational


Primary Outcome

Frequency of exacerbations

Secondary Outcome

 Time to first exacerbation

Condition

Bronchiectasis Adult


Study Arms / Comparison Groups

 Patients with bronchiectasis
Description:  Adult patients with bronchiectasis meeting the inclusion criteria.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1000

Start Date

November 1, 2019

Completion Date

January 1, 2024

Primary Completion Date

February 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James D Chalmers, MD, PhD, 01382660111, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03791086

Organization ID

2017RC11


Responsible Party

Sponsor

Study Sponsor

University of Dundee


Study Sponsor

James D Chalmers, MD, PhD, Principal Investigator, GSK/British Lung Foundation Chair of Respiratory Research


Verification Date

November 2019