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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Frequency of exacerbations
Worsening of respiratory symptoms as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.
Secondary outcomes
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.
Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)
Validated questionnaire
Quality of life- the St Georges Respiratory Questionnaire (SGRQ)
Validated questionnaire
Quality of life- The Bronchiectasis impact measure (BIM)
Questionnaire undergoing validation
Sponsors and contacts
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