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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00876694
Eligibility Criteria:
Inclusion Criteria:
1\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:
* Smoking history of at least 20 pack-years
* Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
Exclusion Criteria:
1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
3. Patients with concomitant pulmonary disease
4. Patients with a history of asthma
5. Patients with diabetes Type I or uncontrolled diabetes Type II
6. Any patient with lung cancer or a history of lung cancer
7. Patients with a history of certain cardiovascular comorbid conditions
8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00876694
Study Brief:
Protocol Section:
NCT00876694