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The London COPD Exacerbation Cohort (EXCEL_Cohort)

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ClinicalTrials.gov Identifier: NCT02755974
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Pulmonary Disease, Chronic Obstructive

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Patient Phenotypes and Exacerbations in Chronic Obstructive Pulmonary Disease.
Study Start Date : January 2009
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD




Primary Outcome Measures :
  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)


Biospecimen Retention:   Samples With DNA
Blood, Sputum, Urine, Bronchoscopy brushing and Lavage fluid, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with COPD who are generally seen in outpatient clinic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755974


Contacts
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Contact: Jadwiga A Wedzicha, MD 2075947947 j.wedzicha@imperial.ac.uk
Contact: Gavin C Donaldson, PhD 207 4947859 gavin.donaldson@imperial.ac.uk

Locations
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United Kingdom
National Heart and Lung Institute, Imperial College Recruiting
London, United Kingdom, SW3 6LR
Contact: Gavin C Donaldson, PhD    44 (0) 207 594 7859    gavin.donaldson@imperial.ac.uk   
Contact: Jadwiga A Wedzicha, MD    44 (0) 207 594 7947    j.wedzicha@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02755974     History of Changes
Other Study ID Numbers: 14|C1925
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive