N/A
Completed N=260
Re-usable Respimat® Soft MistTM Inhaler Study
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04011735 ↗
Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score — 84.26; 81.59; 83.24 Score on a scale
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-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score |
84.26; 81.59; 83.24 | — |
| SECONDARY Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment) |
84.70; 82.88; 82.38 | — |
| SECONDARY Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment) |
83.74; 80.08; 84.24 | — |
| SECONDARY Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment) |
0; 1; 1; 2; 0; 0 | — |
| SECONDARY Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment) |
89.1; 88.0; 84.1 | — |
| SECONDARY Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment) |
0; 3; 1; 4; 2; 0 | — |
| SECONDARY Difference in the Mean Total PASAPQ Score Between Study Entry and Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product |
1.10 | — |
| SECONDARY Number of Patients With Preference for Re-usable or Disposable Respimat SMI at Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product |
57; 8; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT04011735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.