Bronchiectasis AdultBRIDGENCT03791086
The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping
An observational study of Bronchiectasis Adult, run by University of Dundee at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with bronchiectasis
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Dundee
Dundee, DD1 9SY
James D Chalmers, MD,PhD, 01382660111, james.chalmers@nhs.scot
Megan Crichton, Msc, 01382 383694, m.l.crichton@dundee.ac.uk
About this study
Official title: The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping. An EMBARC2 and EMBARC3 Study
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.
Read more
Secondary Objectives
- To determine molecular endotypes of stable bronchiectasis
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- 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.
Read the 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
- To determine the molecular endotypes of bronchiectasis during stable disease
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- 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.
- Conditions
- Bronchiectasis Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bronchiectasis | Adult patients with bronchiectasis meeting the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of exacerbations
Worsening of respiratory symptoms as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.
Measured: up to 3 years
Secondary outcomes (11)
Time to first exacerbation
Time to first event after enrolment as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.
Measured: 3 years
Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)
Validated questionnaire
Measured: 3 years
Quality of life- the St Georges Respiratory Questionnaire (SGRQ)
Validated questionnaire
Measured: 3 years
Quality of life- The Bronchiectasis impact measure (BIM)
Questionnaire undergoing validation
Measured: 3 years
Quality of life- The Bronchiectasis Health Questionnaire (BHQ)
Validated questionnaire
Measured: 3 years
Forced expiratory volume in 1 second (FEV1)
Spirometry
Measured: 3 years
Severity of disease (the bronchiectasis severity index)
Validated severity assessment tool
Measured: 3 years
Hospitalisation for severe exacerbations
Admission to hospital for an exacerbation meeting the EMBARC/BRR exacerbation definition
Measured: 3 years
All cause mortality
Survival during the study
Measured: 3 years
Infection with Pseudomonas aeruginosa
Defined as isolation in sputum culture or bronchoalveolar lavage meeting the criteria for chronic infection- Ann Am Thorac Soc. 2015 Nov;12(11):1602-11.
Measured: 3 years
Sputum volume
Measured in millilitres per day
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Nov 2019
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Chalmers, University of Dundee
- Investigators
- James D Chalmers, MD, PhD, Principal investigator, GSK/British Lung Foundation Chair of Respiratory Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791086
- Sponsor's protocol ID
- 2017RC11
- Acronym
- BRIDGE
- Status last verified
- Mar 2023
- First submitted
- 29 Dec 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from EMBARC supported studies will be made available to researchers. Application for EMBARC data can be made on our website. Further information is available at www.bronchiectasis.eu/dataaccess
Publications
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.
PubMed 39490969
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping. An EMBARC2 and EMBARC3 Study
- ClinicalTrials.gov ID
- NCT03791086
- Acronym / sponsor ID
- BRIDGE / 2017RC11
- Conditions
- Bronchiectasis Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine molecular endotypes of stable bronchiectasis
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- 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
- To determine the molecular endotypes of bronchiectasis during stable disease
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bronchiectasis | – | –Adult patients with bronchiectasis meeting the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with bronchiectasis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of exacerbations
Time frame: up to 3 years
Worsening of respiratory symptoms as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.
11 secondary outcomes
Time to first exacerbation
Time frame: 3 years
Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)
Time frame: 3 years
Quality of life- the St Georges Respiratory Questionnaire (SGRQ)
Time frame: 3 years
Quality of life- The Bronchiectasis impact measure (BIM)
Time frame: 3 years
Quality of life- The Bronchiectasis Health Questionnaire (BHQ)
Time frame: 3 years
Forced expiratory volume in 1 second (FEV1)
Time frame: 3 years
Severity of disease (the bronchiectasis severity index)
Time frame: 3 years
Hospitalisation for severe exacerbations
Time frame: 3 years
All cause mortality
Time frame: 3 years
Infection with Pseudomonas aeruginosa
Time frame: 3 years
Sputum volume
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 39490969Choi 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.
- Individual participant dataSharing planned: Yes. Data from EMBARC supported studies will be made available to researchers. Application for EMBARC data can be made on our website. Further information is available at www.bronchiectasis.eu/dataaccess
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James D Chalmers, MD, PhD principal investigator
GSK/British Lung Foundation Chair of Respiratory Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James D Chalmers, MD, PhD (01382660111, james.chalmers@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of exacerbations (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.