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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01701934
Eligibility Criteria:
Inclusion Criteria:
* Gave an informed consent
* Forced expiratory volume in 1 second \< 80% predicted
* Forced expiratory volume in 1 second / Forced vital capacity \< 70%
* No exacerbation in the last 4 weeks
* Current or ex-smoker
* Smoking history of at least 10 pack/year
* Body mass index of at least 25 kg/m2
* Waist circumference of at least 94 cm
* Fasting blood triglycerides of at least 1.7 mmol/L
Exclusion Criteria:
* Any significant pulmonary pathology other than COPD
* Under oxygen therapy more than 12 hours per day
* More than 2 exacerbation episodes in the last 12 months
* The patient is currently participating to the active phase of a rehabilitation program
* Patient has been under roflumilast therapy prior to enrollment
* Unstable hypertriglyceridemia or hypercholesterolemia
* Under diabetes therapy (hypoglycemic agent or insulin)
* Cancer history in the last 5 years (except basal cell carcinoma)
* Moderate or severe hepatic impairment
* Used prednisone or systemic corticosteroids in the last 4 weeks
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01701934
Study Brief:
Protocol Section:
NCT01701934