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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01473758
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent (IC)
* Age ≥ 40 years
* History of COPD for at least 12 months prior to enrollment (Visit V0)
* Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrollment
* Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour
* Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) \< 70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months)
* Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years
Main Exclusion Criteria:
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Recurrent exacerbations (within 8 weeks of a preceding exacerbation)
* Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrollment
* Treatment with PDE4 inhibitors within 3 months prior to Visit V0
* Other protocol-defined exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01473758
Study Brief:
Protocol Section:
NCT01473758