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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT02182635
Eligibility Criteria:
Inclusion Criteria:
The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
1. Patients with FEV1.0/FVC (Forced vital capacity) of \<= 70% in the screening test and whose symptoms are stable
2. Patients aged \>= 40 years or older
3. Patients must be able to understand the patient information form
Exclusion Criteria:
1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
4. Patients with glaucoma
5. Patients who have prostatic hypertrophy
6. Patients with hypersensitivity to anticholinergic drugs
7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
8. Women who are pregnant or who may become pregnant, or nursing women
9. Patients who are judged by the investigator as inappropriate as the subjects of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02182635
Study Brief:
Protocol Section:
NCT02182635