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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02125734
Eligibility Criteria:
Inclusion Criteria:
* signed an Informed Consent Form
* stable COPD according to current guidelines (GOLD 2013)
* airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \<0.70 and a post-bronchodilator FEV1 of ≥30% and \<80% of predicted normal values at Visit 2.
* current or ex-smokers who have a smoking history of at least 10 pack years
* Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
* Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).
Exclusion Criteria:
* Pregnant or breast feeding mothers
* Patients with conditions contraindicated for treatment
* Patients with a history of clinically significant diseases
* Patients who have a clinically significant renal disease
* Patients with myocardial infarctions less than 6 months prior to study entry
* Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
* Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
* Patients with a history of malignancy of any organ system
* Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
* Patients who have had a respiratory tract infection within 6 weeks prior to Screening
* Patients with any history of asthma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02125734
Study Brief:
Protocol Section:
NCT02125734