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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT00917150
Eligibility Criteria:
Inclusion Criteria:
* Age 40 to 75 years, inclusive, at the time informed consent is obtained
* Ability to provide own written informed consent
* Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
* A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
* Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
* Cigarette smoking history of at least 20 pack years at screening
Exclusion Criteria:
* Subjects with obstructive disorders due to bronchial asthma
* Subjects receiving long-term oxygen therapy
* Subjects with active tuberculosis or obvious bronchiectasis
* Complication of malignant tumor
* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
* Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00917150
Study Brief:
Protocol Section:
NCT00917150