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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Dundee

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Adult patients with bronchiectasis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Patients with bronchiectasis

Trial outcomes

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.

Time frame
up to 3 years

Secondary outcomes

1

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.

Time frame
3 years
2

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

Validated questionnaire

Time frame
3 years
3

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

Validated questionnaire

Time frame
3 years
4

Quality of life- The Bronchiectasis impact measure (BIM)

Questionnaire undergoing validation

Time frame
3 years

Other outcomes

Sponsors and contacts

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