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 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT00242320
Eligibility Criteria:
Main Inclusion Criteria:
* Written informed consent
* Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
* FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
* FEV1 (post bronchodilator) 30-80% of predicted
* Fixed airway obstruction
* Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
* Clinically stable COPD within 4 weeks prior to baseline visit
* Availability of a chest x-ray
Main Exclusion Criteria:
* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
* Lower respiratory tract infection
* Diagnosis of asthma
* Known alpha-1-antitrypsin deficiency
* Need for long term oxygen therapy defined as longer or equal 16 hours/day
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
* Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
* Diagnosis or history of cancer
* Clinically significant cardiopulmonary abnormalities
* Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
* Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal \> 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
* Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
* Alcohol or drug abuse
* Inability to follow the study procedures due to e.g., language problems, physiological disorders
* Use of not allowed drugs
* Suspected hypersensitivity to the study medication or rescue medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00242320
Study Brief:
Protocol Section:
NCT00242320