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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT01708057
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
* Clinical diagnosis of COPD for more than 1 year at Visit 1
* FEV1 ≥ 30 to \< 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC \< 70%
* Reversible airway obstruction
Exclusion Criteria:
* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
* An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
* Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
* Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
* Long-term oxygen therapy, as judged by the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01708057
Study Brief:
Protocol Section:
NCT01708057