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NCT Number: NCT02755974

The London COPD Exacerbation Cohort

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Heart and Lung Institute, Imperial College

London, SW3 6LR, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Annual exacerbation rate (number of exacerbations over a 12 month period)

    Time frame: 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)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: EXCEL_Cohort

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2016
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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