Re-usable Respimat® Soft MistTM Inhaler Study
A Real-world Non-interventional Study to Assess Patient Satisfaction With and Preference for Re-usable Respimat Soft Mist Inhaler in Patients With Chronic Obstructive Pulmonary Disease.
1 other identifier
observational
262
6 countries
20
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2020
CompletedResults Posted
Study results publicly available
March 3, 2021
CompletedMarch 3, 2021
February 1, 2021
5 months
July 4, 2019
February 11, 2021
February 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score
Total PASAPQ score is a measure of patient's satisfaction regarding the handling of the re-usable Respimat® SMI. The total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13). Each PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction: Performance score = 100 \*\[(Q1+Q2 +Q3+ Q4+Q5+Q10+Q11)-7\] /(49-7) Convenience score = 100 \*\[(Q6+ Q7+Q8+Q9+Q12+Q13)-6\] / (42-6) Total score = 100 \*\[(Q1+Q2 +Q3+Q4+ Q5+Q6 + Q7+Q8+ Q9+Q10+Q11+Q12+Q13)-13\] / (91-13)
At follow-up assessment, 4 to 6 weeks after baseline.
Secondary Outcomes (7)
Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)
At follow-up assessment, 4 to 6 weeks after baseline.
Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)
At follow-up assessment, 4 to 6 weeks after baseline.
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
At follow-up assessment, 4 to 6 weeks after baseline.
Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)
At follow-up assessment, 4 to 6 weeks after baseline.
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
At follow-up assessment, 4 to 6 weeks after baseline.
- +2 more secondary outcomes
Study Arms (3)
Respimat SMI-experienced: Switching to re-usable Respimat
patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry.
Respimat SMI-naïve
patients who have not previously used a Respimat SMI product and receive their first prescription at study entry
Respimat SMI-experienced: Maintenance treatment
patients who have been on maintenance treatment with a Respimat SMI product and receive a refill prescription at study entry.
Interventions
Soft Mist Inhaler product
Eligibility Criteria
The study is planned that approximately with 250 Chronic Obstructive Pulmonary Disease (COPD) patients (Respimat SMI-experienced and Respimat SMI-naïve) from Europe will be enrolled in this study.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Brussels - UNIV UZ Brussel
Brussels, 1090, Belgium
Clinique Notre-Dame de Grâce
Gosselies, 6041, Belgium
Roeselare - HOSP AZ Delta
Menen, 8930, Belgium
Hvidovre Hospital
Hvidovre, 2650, Denmark
Vejle Hospital
Vejle, 7100, Denmark
TYKS, Keuhkosairauksien klinikka, Turku
Turku, 20520, Finland
Universitätsklinikum Aachen, AöR
Aachen, 52074, Germany
MECS Research GmbH, Berlin
Berlin, 12203, Germany
KPPK GmbH, Studienzentrum
Koblenz, 56068, Germany
Pneumologiezentrum Leipzig
Leipzig, 04207, Germany
Pneumologische Schwerpunktpraxis, 23558 Lübeck
Lübeck, 23558, Germany
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
Gelre Ziekenhuis Zutphen
Zutphen, 7207 AE, Netherlands
Frisk Utvikling Helse AS
Elverum, N-2402, Norway
Hisøy Legesenter
Kolbjørnsvik, N-4816, Norway
Lambertseter Legesenter
Oslo, N-1157, Norway
Svelvik Legesenter
Svelvik, N-3060, Norway
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
July 8, 2019
Study Start
September 30, 2019
Primary Completion
February 13, 2020
Study Completion
February 13, 2020
Last Updated
March 3, 2021
Results First Posted
March 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial\_results/ clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.