The London COPD Exacerbation Cohort

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT02755974
• Lead Sponsor: Imperial College London

Brief Summary

The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.

Detailed Description

Our intentions are to phenotype Chronic Obstructive Pulmonary Disease (COPD) patients on the basis of factors that a related to (a) exacerbation frequency which will include (b) lung function to assess disease severity, (c) baseline therapy, (d) airway and systemic inflammatory markers, (e) health status, (f) gene expression, (g) airway bacterial and viral load and (h) co-morbidity including cardiovascular disease, diabetes and psychological disease, (i) psychological factors,(j) mortality, (k) nasal susceptibility to rhinovirus infection, (l) heart rate variability (m) exhaled hydrogen sulphide.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of <0.70
• Able and willing to give informed and written consent

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Exclusion Criteria

• Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded.
• Patients on Immunosuppressive medications or with active cancer
• Long term steroid therapy
• Age <40 years at recruitment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual exacerbation rate (number of exacerbations over a 12 month period)	12 months	Definition of an exacerbation; * The presence of 2 new symptoms (one of which must be major) for 2 consecutive days; * Major symptoms: increased breathlessness (A), increased sputum colour (B1) or increased sputum amount (B2); * Minor symptoms: a cold (C), increased wheeze or chest tightness (D), Sore throat (E1), Increased cough (E2), Fever (F)

Trial Locations

Locations (1)

National Heart and Lung Institute, Imperial College; 🇬🇧 London, United Kingdom