A comprehensive disease characterisation study in adult bronchiectasis

Not Applicable

• Conditions: Bronchiectasis; Respiratory

• Registration Number: ISRCTN15320623
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-27
• Last Update Posted: 29 July 2024
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Bronchiectasis cohort:
1. Age >18 years
2. Bronchiectasis diagnosed by CT scan
3. Symptoms consistent with bronchiectasis: cough, sputum and/or frequent respiratory tract infections
4. Clinically stable defined by the absence of antibiotic therapy in the previous 4 weeks

Healthy control cohort:
1. Age >18 years

Exclusion Criteria

Bronchiectasis cohort:
1. A primary diagnosis of asthma or COPD (secondary diagnoses and individuals with historical misdiagnosis will be permitted)
2. Immunodeficiency requiring immunoglobulin replacement therapy
3. Active allergic bronchopulmonary aspergillosis (defined by receipt of oral corticosteroids or anti-fungal therapy)
4. Active tuberculosis
5. Traction bronchiectasis due to interstitial lung disease
6. Active SARS-CoV-2 infection or contact with a confirmed case in the previous 14 days
7. Active malignancy excluding non-melanoma skin cancer
8. Antibiotic treatment for an acute respiratory tract infection or exacerbation in the previous 4 weeks
9. Treatment with anticoagulants
10. Any contraindication to study procedures including bronchoscopy
11. Current smoking or smoking in the preceding 3 months

Healthy control cohort:
1. Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment)
2. Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, and any other connective tissue disease
3. Active SARS-CoV-2 infection or contact with a confirmed case in the previous 14 days
4. Active malignancy excluding non-melanoma skin cancer
5. Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks
6. Any contraindication to study procedures including bronchoscopy
7. Current smoking or smoking in the preceding 3 months
8. Upper respiratory tract infection in the previous 4 weeks or current sinusitis
9. Treatment with anticoagulants

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The molecular endotypes of bronchiectasis during stable disease, determining by integrating data from multiple sources including clinical, inflammatory, microbiological, mucociliary and pathological assessments to identify candidate endotypes. Cross-sectional at baseline (single timepoint).

Secondary Outcome Measures

Name	Time	Method
Biological characteristics measured at a single time point:<br>1.1. Inflammatory markers – including blood eosinophils, serum biomarkers<br>1.2. Microbiology – including BAL culture and sequencing<br>1.3. Lung physiology – including Spirometry and lung function testing<br>