Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00122694
Eligibility Criteria:
Inclusion Criteria:
* Men and women, age \> 40 years. Women must be post-menopausal (i.e. at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator.
* A diagnosis of COPD according to the criteria of the American Thoracic Society (ATS); a disease state characterised by the presence of chronic airway obstruction due to chronic bronchitis (cough/sputum on most days a week for 3 months a year for at least two successive years); or emphysema.
* FEV1 \> 0.7 litres
* FEV1/FVC ratio \< 70% (equation retrieval system \[ERS\] equations)
* A smoking history of \> 10 pack years
* Completely stopped smoking \> 1 year ago
* No upper or lower respiratory tract infection in the last 4 weeks
* In a stable phase of COPD, as judged by the investigator
* Signed and dated informed consent obtained before any study related procedures (including withdrawal of concomitant medication) are conducted
Exclusion Criteria:
* Treatment with immune-modulating agents for any other disease
* History of asthma; former diagnosis of asthma
* Arterial oxygen tension (PaO2) \< 8.0 kPa
* Any significant other pulmonary disease or disorder (e.g. alpha1-antitrypsin deficiency, bronchiectasies), as judged by the investigator
* Patients with other significant disease or disorder (like cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic \[including diagnosed diabetes\], malignant, psychiatric, major physical impairment), which, in the opinion of the investigator may either put the patient at risk because of participation in the study; or may influence the results of the study, or the patient's ability to participate in the study.
* Patients unable to blow reproducable lung function measurements
* Patients using medicine with anti-oxidant character like n-acetyl-cysteine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00122694
Study Brief:
Protocol Section:
NCT00122694