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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01415518
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent
* Men or women patients ≥ 40 years of age
* Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
* Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
* Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
Exclusion Criteria:
* A history of asthma and seasonal allergic rhinitis before 40 years of age
* Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period
* Patients with relevant cardiovascular disorder judged by the investigator
* Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
* Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01415518
Study Brief:
Protocol Section:
NCT01415518