Markers for Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00180622

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2001-07-01

Study Completion Date

2002-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy Non-smokers Current Smokers COPD Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Spirometry

Intervention Type PROCEDURE

Exhaled Nitric Oxide and Carbon Monoxide

Intervention Type PROCEDURE

Exhaled Breath Condensate

Intervention Type PROCEDURE

Induced Sputum

Intervention Type PROCEDURE

CT Scan

Intervention Type PROCEDURE

Blood test

Intervention Type PROCEDURE

St Georges Questionnaire

Intervention Type PROCEDURE

Bodypletysmography

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergei A Kharitonov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Peter J Barnes, MA DM DSc FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SD-000-068

Identifier Type: -

Identifier Source: org_study_id

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