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Eclipse extension.

Completed
Conditions
COPD, biological markers
Registration Number
NL-OMON29112
Lead Sponsor
Centrum:CIRO+, expertisecentrum voor chronisch orgaanfalen.Plaats:HornHoofdonderzoeker:Prof. Dr. E.F.M. Wouters
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Male or female subjects, aged 40-75 years inclusive;

Exclusion Criteria

A COPD subject will not be eligible for inclusion in this study only if all of the following criteria apply:

1. 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);

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary study parameters of ECLIPSE extension with an additional three years follow-up are:<br /><br>1. The 6 years natural history of the following phenotypes of COPD: GOLD stage II till IV; cachexia; respiratory failure; frequent exacerbators; and predominantly emphysema and predominantly airway disease;<br /><br>2. The relationship between the progressions of the above phenotypes;<br /><br>3. How the baseline data of ECLIPSE predicts the above phenotypes;<br /><br>4. How the progression of the above phenotypes relates to all-cause mortality and mortality of COPD.
Secondary Outcome Measures
NameTimeMethod
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