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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT03197818
Eligibility Criteria:
Inclusion Criteria:
* Male or Female adults aged \> 40 years with a diagnosis of COPD
* Current smokers or ex-smokers
* A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \< 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
* At least one exacerbation in the 12 months preceding the screening visit
Exclusion Criteria:
* Pregnant or lactating women
* Diagnosis of asthma, history of allergic rhinitis or atopy
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
* Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03197818
Study Brief:
Protocol Section:
NCT03197818