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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT01233232
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of COPD with symptoms for more than one year before screening
* Body mass index of 18-30 kg/m2 and weight of 50-100kg
* Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
* FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
* FEV1/FVC less than 70% post-bronchodilator at screening
Exclusion Criteria:
* Any clinically significant disease or disorder
* Exacerbation of COPD which was not resolved within 30 days of first dosing
* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
* Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
* Disease history suggesting reduced or abnormal immune function other than that related to COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01233232
Study Brief:
Protocol Section:
NCT01233232