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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT03137992
Eligibility Criteria:
Inclusion Criteria:
* Male and non-pregnant female subjects (40 years of age and older).
* Patients with diagnosis of COPD according to the GOLD guidelines.
* Post-bronchodilator FEV1 \<80% of the predicted value at the screening visit.
* Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
* Current or former smokers (e.g., with history of = 10 pack-years).
* Written informed consent.
Exclusion Criteria:
* Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
* History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
* Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
* Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
* Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
* Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03137992
Study Brief:
Protocol Section:
NCT03137992