Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Novel endpoint determination

• Registration Number: NCT00292552
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-16
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2747

Inclusion Criteria

Not provided

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Exclusion Criteria

COPD Subjects

• A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
• Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
• Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
• Having undergone lung surgery (e.g. lung reduction, lung transplant)
• Have cancer or have had cancer in the 5 years prior to study entry
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
• Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans)
• Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
• Have received a blood transfusion in the 4 weeks prior to study start
• Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 2 weeks before study start
• Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
• Unable to walk
• Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.

Control Subjects

• A control subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Known respiratory disorders, or disorders identified at screening/visit 1 including identification on the first CT scan (e.g.: COPD, asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis)
• Known history of significant inflammatory disease (eg rheumatoid arthritis and Lupus)
• Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
• Having undergone lung surgery (e.g. lung reduction, lung transplant)
• Have cancer or have had cancer in the 5 years prior to study entry
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study
• Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans)
• Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
• Have received a blood transfusion in the 4 weeks prior to study start
• Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
• Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD subjects	Novel endpoint determination	Subjects with GOLD stage II-IV COPD
Non-smoker controls	Novel endpoint determination	Normal healthy non-smokers
Smoker controls	Novel endpoint determination	Subjects with smoking history but normal lung function

Primary Outcome Measures

Name	Time	Method
Identifying new patient subtypes and endpoints for COPD	3 years

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, United Kingdom