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.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Respimat

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Brussels - UNIV UZ Brussel
  • Gosselies, Belgium, 6041
    • Clinique Notre-Dame de Grâce
  • Menen, Belgium, 8930
    • Roeselare - HOSP AZ Delta
• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Vejle, Denmark, 7100
    • Vejle Hospital
• Finland
  • Turku, Finland, 20520
    • TYKS, Keuhkosairauksien klinikka, Turku
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, AöR
  • Berlin, Germany, 12203
    • MECS Research GmbH, Berlin
  • Koblenz, Germany, 56068
    • KPPK GmbH, Studienzentrum
  • Leipzig, Germany, 04207
    • Pneumologiezentrum Leipzig
  • Lübeck, Germany, 23558
    • Pneumologische Schwerpunktpraxis, 23558 Lübeck
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Rotterdam, Netherlands, 3045 PM
    • Franciscus Gasthuis
  • Zutphen, Netherlands, 7207 AE
    • Gelre Ziekenhuis Zutphen
• Norway
  • Elverum, Norway, N-2402
    • Frisk Utvikling Helse AS
  • Kolbjørnsvik, Norway, N-4816
    • Hisøy Legesenter
  • Oslo, Norway, N-1157
    • Lambertseter Legesenter
  • Svelvik, Norway, N-3060
    • Svelvik Legesenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Respimat; Soft Mist Inhaler product; Other Names: (Spiriva®, Striverdi® or; Spiolto®)
Respimat SMI-naïve; patients who have not previously used a Respimat SMI product and receive their first prescription at study entry	Drug: Respimat; Soft Mist Inhaler product; Other Names: (Spiriva®, Striverdi® or; Spiolto®)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)	The performance domain score of PASAPQ contained 7 items (Q 1-5 and 10-11), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction: Performance score = 100 * [(Q1+ Q2+Q3+Q4+Q5+Q10+Q11)-7] / (49-7)	At follow-up assessment, 4 to 6 weeks after baseline.
Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)	The convenience domain score of PASAPQ contained 6 items (Question 6-9 and 12-13), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction: Convenience score = 100 * [(Q6+Q7+Q8+Q9+Q12+Q13)-6] / (42-6)	At follow-up assessment, 4 to 6 weeks after baseline.
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)	The overall satisfaction score of the PASAPQ asked for the overall satisfaction with the device used in the study (Question 14), answered using a 7-point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by category.	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)	To assess the willingness to continue with inhaler, the following questions was asked: "How would you feel about continuing to use the inhaler?", using a value from 0-100, with zero indicating that the patient is not willing to continue using the inhaler and 100 indicating that the patient is definitely willing to continue using the inhaler.	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)	10 Questions regarding the Ease of Handling were asked, using a 7 point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by answer category.	At follow-up assessment, 4 to 6 weeks after baseline.
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	Difference in the mean Total PASAPQ score between study entry (baseline visit) and at study end (follow-up assessment) in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry. 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.	At study entry (baseline) and at study end (4 to 6 weeks after baseline).
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	Number of patients with preference for re-usable or disposable Respimat SMI at study end (follow-up assessment), in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry. To assess the preference for inhaler, following question was asked: "Comparing the re-usable with disposable inhaler, which inhaler do you prefer to use?"	At follow-up assessment, 4 to 6 weeks after baseline.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): February 13, 2020
• Study Completion (ACTUAL): February 13, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 1237-0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No