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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT01388920
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 40-75 years (y) inclusive
* Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)
* Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening
* Able to participate in a supervised exercise training program
* Evidence of muscle wasting
Exclusion Criteria
* Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening
* More than 4 exacerbations in the year prior to screening
* Life-threatening exacerbation in the year prior to screening
* Requirement for long-term oxygen therapy (\> 12 hours of oxygen per day)
* Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements
* Use of agents known to increase lean body mass within 3 months prior to screening
* Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01388920
Study Brief:
Protocol Section:
NCT01388920