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Markers for COPD

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180622
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
Healthy Non-Smokers
Current Smokers
COPD Patients
 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 Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Non-Invasive Markers for COPD

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Further study details as provided by Imperial College London:

Estimated Enrollment: 52
Study Start Date: July 2001
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180622

Locations
United Kingdom
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180622     History of Changes
Other Study ID Numbers: SD-000-068
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Carbon Monoxide
Nitric Oxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013