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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT01849159
Eligibility Criteria:
Inclusion Criteria:
* HRCT-confirmed diagnosis of lung emphysema by two independent radiologists
* post-bronchodilator FEV1/FVC ratio \< 0.7
* post-bronchodilator FEV1 % predicted value ≥ 20% and \< 50%
* age 35 and 75 years of, of either sex, and of any race
* current or ex-smoker, with a cigarette smoking history ≥ 10 pack-years
Exclusion Criteria:
* • asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, or lung cancer)
* α1-Antitrypsin deficiency
* Presence of bullae (more than 10 cm in the diameter)
* active infection within 4 weeks of screening
* significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening
* clinically relevant uncontrolled medical condition not associated with COPD
* documented history of uncontrolled heart failure
* pulmonary hypertension due to left heart condition
* Subject has evidence of active malignancy, or prior history of active malignancy
* Subject has a life expectancy of \< 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT01849159
Study Brief:
Protocol Section:
NCT01849159