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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03663569
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to participation
* Female and male patients ≥40 years of age
* Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines
Exclusion Criteria:
* Patients with contraindications according to Spiolto® Respimat® SmPC
* Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
* Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Pregnancy and lactation
* Current participation in any clinical trial or any other non-interventional study of a drug or device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03663569
Study Brief:
Protocol Section:
NCT03663569