Status:
COMPLETED
Re-usable Respimat® Soft MistTM Inhaler Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-exp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2020
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04011735
Start Date
September 30 2019
End Date
February 13 2020
Last Update
March 3 2021
Active Locations (20)
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1
Brussels - UNIV UZ Brussel
Brussels, Belgium, 1090
2
Clinique Notre-Dame de Grâce
Gosselies, Belgium, 6041
3
Roeselare - HOSP AZ Delta
Menen, Belgium, 8930
4
Hvidovre Hospital
Hvidovre, Denmark, 2650