Markers for Chronic Obstructive Pulmonary Disease (COPD)

July 2, 2019 updated by: Imperial College London

Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6LY
        • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2001

Primary Completion (Anticipated)

July 1, 2002

Study Completion (Anticipated)

July 1, 2002

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-000-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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