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Markers for Chronic Obstructive Pulmonary Disease (COPD)

Sponsor
Imperial College London (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00180622
Collaborator
AstraZeneca (Industry)
0
Enrollment
1
Location
12
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spirometry
  • Procedure: Exhaled Nitric Oxide and Carbon Monoxide
  • Procedure: Exhaled Breath Condensate
  • Procedure: Induced Sputum
  • Procedure: CT Scan
  • Procedure: Blood test
  • Procedure: St Georges Questionnaire
  • Procedure: Bodypletysmography

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)
Anticipated Study Start Date :
Jul 1, 2001
Anticipated Primary Completion Date :
Jul 1, 2002
Anticipated Study Completion Date :
Jul 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Healthy non-smokers

    • FEV1 >80% predicted

    • FEV1 reversibility of <10% after inhaled (beta2-agonists

    Current smokers

    • FEV1 no less than 80% predicted

    • FEV1 reversibility of <10% after inhaled (beta2-agonists

    • Smoking history of > 10 pack-years

    Moderate COPD

    • FEV1 40-59% predicted

    • FEV1 reversibility of <10% after inhaled (beta2-agonists

    • Smoking history of > 10 pack-years**

    Severe COPD

    • FEV1 <40% predicted

    • FEV1 reversibility of <10% after inhaled (beta2-agonists

    • Smoking history of > 10 pack-years

    Exclusion Criteria:

    • FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists

    • Asthma

    • unstable disease (FEV1 <35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital London United Kingdom SW3 6LY

    Sponsors and Collaborators

    • Imperial College London
    • AstraZeneca

    Investigators

    • Principal Investigator: Sergei A Kharitonov, MD PhD, Imperial College London
    • Principal Investigator: Peter J Barnes, MA DM DSc FRCP, Imperial College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT00180622
    Other Study ID Numbers:
    • SD-000-068
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Nitric Oxide
    Carbon Monoxide

    Study Results

    No Results Posted as of Jul 5, 2019