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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT04011735
Eligibility Criteria:
Inclusion Criteria:
Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:
* Provision of signed informed consent prior to study data collection
* Patient with COPD aged 40 years or older
* Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
* Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)
Exclusion Criteria:
Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:
* Patient using a disposable Respimat SMI product during the study period
* Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
* Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
* Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
* Patient not fluent and literate in one of the main languages of the country
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04011735
Study Brief:
Protocol Section:
NCT04011735