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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01232894
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
* Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)
Exclusion Criteria:
* Patients with a history of asthma
* Patients who are currently being treated for COPD with tiotropium (Spiriva®)
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of certain cardiovascular comorbid conditions
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01232894
Study Brief:
Protocol Section:
NCT01232894