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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00396604
Eligibility Criteria:
Inclusion Criteria:
* Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
* Smoking history of at least 10 pack years
* FEV1 less than 65% of the predicted normal value and at least 0.75 L
* Pre-bronchodilator FEV1/FVC less than 70%
Exclusion Criteria:
* A history of asthma or COPD diagnosis before the age of 40
* Hospitalization for COPD exacerbation within the previous 6 weeks
* Respiratory tract infection within 6 weeks
* Use of long-term oxygen therapy
* Diabetes type I or uncontrolled diabetes type II
* Clinically relevant laboratory abnormality or clinically significant condition
* Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00396604
Study Brief:
Protocol Section:
NCT00396604