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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT02988869
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥40 years with COPD diagnosis according to the current GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy.
* Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio \<0.70, and FEV1 \<80% of predicted normal at screening visit.
* Current smokers or ex-smokers with a smoking history of at least 10 pack-years
* Patients who have no exacerbation within last 4 weeks
* Female patients with childbearing potential using effective birth control method
* Patients who signed written informed consent prior to participation
* Patients who accept to comply with the requirements of the protocol
* Patients who have a capability of communicate with investigator
Exclusion Criteria:
* History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose
* Diagnosis of asthma
* Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period.
* Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period.
* Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks
* Patients who have lung cancer
* Patients with active tuberculosis
* Patients who use oxygen therapy
* Patients who have common interstitial lung diseases like cystic fibrosis, bronchiolitis obliterans
* Patients with serious liver or renal disease that leads to organ failure
* Women who are pregnant or nursing
* History of allergic rhinitis and atopy
* Known symptomatic prostatic hypertrophy requiring drug therapy or operation
* Patients with narrow-angle glaucoma requiring drug therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02988869
Study Brief:
Protocol Section:
NCT02988869