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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT03395002
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥40 years with 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/FVC ratio \<0.70, and FEV1 \<80% of predicted normal value at screening visit.
* Patients with a mMRC score ≥2
* Current smokers or ex-smokers with a smoking history of at least 10 pack-years
* Patients who have an exacerbation within least a year and no exacerbation within last 4 weeks
* Females patients with childbearing potential using effective birth control method
* 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 drugs contains long acting beta-2 agonists, corticosteroids, anticholinergics or lactose.
* History of asthma or significant chronic respiratory diseases except COPD.
* 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 with serum potassium level ≤ 3.5 mEq/L or \>5.5 mEq/L
* Patients who used systemic corticosteroids or immunosupresants within 4 weeks prior to study onset
* 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 who had lung volume reduction operation
* Patients who had 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 or atopy
* Known symptomatic prostatic hypertrophy requiring drug therapy or operation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT03395002
Study Brief:
Protocol Section:
NCT03395002