COPD, biological markers
Conditions
Interventions
None listed
Sponsors
Centrum: CIRO+, expertisecentrum voor chronisch orgaanfalen.
Plaats: Horn
Hoofdonderzoeker:Prof. Dr. E.F.M. Wouters
Eligibility
Inclusion criteria
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; 2. A baseline (post-bronchodilator) FEV1 85% of predicted normal and a baseline (postbronchodilator) FEV1/FVC ratio > 70%; 3. Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g. 20 cigarettes per day for 10 years, or 10 cigarettes for 20 years); 4. A signed and dated written informed consent is obtained prior to participation; 5. Able to comply with the requirements of the protocol and be available for study visits over 3 years. For the ECLIPSE extension: 6. ECLIPSE participants willing and able to continue in a 3-year extension; 7. A signed and dated written informed consent for the extra 3 year of follow up is obtained prior to participation. A non-smoking control 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, who are free from significant disease as determined by history, physical examination and screening investigations; 2. A baseline (post-bronchodilator) FEV1 > 85% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio > 70%; 3. Non-smokers with a smoking history < 1 pack-year (number of pack years = (number of cigarettes per day / 20) x number of years smoked); 4. A signed and dated written informed consent is obtained prior to participation; 5. Able to comply with the requirements of the protocol and be available for study visits over 3 years. For the ECLIPSE extension: 6. ECLIPSE participants willing and able to continue in a 3-year extension; 7. A signed and dated written informed consent for the extra 3 year of follow up is obtained prior to participation.
Exclusion criteria
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); 2. Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus); 3. Known to be severely alpha-1-antitrypsine deficient (PI SZ or ZZ); 4. Having undergone lung surgery (e.g. lung reduction, lung transplant); 5. Have cancer or have had cancer in the 5 years prior to study entry; 6. Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety; 7. 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); 8. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse; 9. Have received a blood transfusion in the 4 weeks prior to study start; 10. 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; 11. Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months); 12. Unable to walk; 13. Subject is participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned. For the ECLIPSE extension: 14. Known significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus); 15. Having undergone lung surgery (e.g. lung reduction, lung transplant); 16. Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety; 17. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. A control subject will not be eligible for inclusion in this study only if all of the following criteria apply: 14. 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); 15. Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus); 16. Known to be severely alpha-1-antitrypsine deficient (PI SZ or ZZ); 17. Having undergone lung surgery (e.g. lung reduction, lung transplant); 18. Have cancer or have had cancer in the 5 years prior to study entry; 19. Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study; 20. 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); 21. Have, in the opinion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters of ECLIPSE extension with an additional three years follow-up are: 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; 2. The relationship between the progressions of the above phenotypes; 3. How the baseline data of ECLIPSE predicts the above phenotypes; 4. How the progression of the above phenotypes relates to all-cause mortality and mortality of COPD. | — |
Contacts
Public ContactMiriam Groenen
Postbus 4080
Outcome results
None listed