The London COPD Exacerbation Cohort

Pulmonary Disease, Chronic Obstructive Clinical Trial

— EXCEL_Cohort  

Official title:

Relationship Between Patient Phenotypes and Exacerbations in Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755974
• Other study ID #: 14IC1925
• Status: Recruiting
• Start date: January 2009
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2022
• Source: Imperial College London
• Contact: Jadwiga A Wedzicha, MD
• Phone: 2075947947
• Email: j.wedzicha[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute, Imperial College	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual exacerbation rate (number of exacerbations over a 12 month period)	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)	12 months