An observational study in Bronchiectasis Adult, sponsored by University of Dundee. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by University of Dundee · Observational
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
This is an observational cohort study that will aim to identify patient subgroups and link these with meaningful clinical outcomes.
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
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.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 160 across 137 observational studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →University of Dundee is the lead sponsor of 113 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with bronchiectasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with bronchiectasis meeting the inclusion criteria.
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
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
Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)
Validated questionnaire
Time frame: 3 years
Quality of life- the St Georges Respiratory Questionnaire (SGRQ)
Validated questionnaire
Time frame: 3 years
Quality of life- The Bronchiectasis impact measure (BIM)
Questionnaire undergoing validation
Time frame: 3 years
Quality of life- The Bronchiectasis Health Questionnaire (BHQ)
Validated questionnaire
Time frame: 3 years
Forced expiratory volume in 1 second (FEV1)
Spirometry
Time frame: 3 years
Severity of disease (the bronchiectasis severity index)
Validated severity assessment tool
Time frame: 3 years
Hospitalisation for severe exacerbations
Admission to hospital for an exacerbation meeting the EMBARC/BRR exacerbation definition
Time frame: 3 years
All cause mortality
Survival during the study
Time frame: 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.
Time frame: 3 years
Sputum volume
Measured in millilitres per day
Time frame: 3 years
Plan to share: 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
Supporting information: Study protocol, Informed consent form, Clinical study report, 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
No publications or documents are linked to this record.
Started Nov 2019 (actual). Primary completion is estimated for Feb 2027, 87 months after the start.
Of 62 observational studies under Bronchiectasis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12. This study's planned 87 months is above that.
How these figures are worked out, and which studies are left out of them.
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