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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT02541006
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 40 years and older with moderate to severe COPD diagnosis
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Have no excacerbation within last 4 weeks
* Hava capability of communicate with investigator
* Accept to adapt the procedures of study protocol
* Signed and dated informed consent
Exclusion Criteria:
* History of hypersensitivity to anticholinergics
* Diagnosis of asthma
* History of alergic rinit and athopy
* Current or history of lung cancer
* Known symptomatic prostatic hypertrophy requiring drug therapy
* Known narrow-angle glaucoma requiring drug therapy
* Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period
* Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period
* Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy
* Women who are pregnant or lactating or are planning on becoming pregnant during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02541006
Study Brief:
Protocol Section:
NCT02541006