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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT01448850
Eligibility Criteria:
Inclusion Criteria:
* Age 45 through 75 years
* Predicted (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II, III, and IV) at Screening
* History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
* Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
* Current smoker or ex-smoker with a tobacco history of more than or equal to (\>=) 10 pack-years.
Exclusion Criteria:
* Past or present disease or disorder,
* Significant or unstable ischemic heart disease etc
* Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
* Past or current malignancy within the past 5 years
* Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
* Use of immunosuppressive medication receipt of any biologic agent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01448850
Study Brief:
Protocol Section:
NCT01448850