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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT03363503
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy
* Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \<0.70, and FEV1 ≥30% and \<80% of predicted normal value 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
* Females patients with childbearing potential using effective birth control method
* Patients whose medication unchanged within least 4 weeks
* Patients who has a capability of communicate with investigator
* Patients who accept to comply with the requirements of the protocol
* Patients who signed written informed consent prior to participation
Exclusion Criteria:
* History of hypersensitivity to long acting beta-2 agonists or corticosteroids
* History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
* 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
* Use of immunosupresants or systemic corticosteroids within least 4 weeks
* History of severe cardiac arrhythmia or myocardial infarction within less than 6 months
* Significant or uncontrolled disease that may preclude participant from participating in the study
* Diognosis of cancer
* History of lung volume reduction operation
* Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period
* Women patients who are pregnant or nursing
* History of allergic rhinitis and atopy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT03363503
Study Brief:
Protocol Section:
NCT03363503