Re-usable Respimat® Soft MistTM Inhaler Study

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011735
• Other study ID #: 1237-0097
• Status: Completed
• Start date: September 30, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: February 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Respimat
Soft Mist Inhaler product

Locations

Country	Name	City	State
Belgium	Brussels - UNIV UZ Brussel	Brussel
Belgium	Clinique Notre-Dame de Grâce	Gosselies
Belgium	Roeselare - HOSP AZ Delta	Menen
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Vejle Hospital	Vejle
Finland	TYKS, Keuhkosairauksien klinikka, Turku	Turku
Germany	Universitätsklinikum Aachen, AöR	Aachen
Germany	MECS Research GmbH, Berlin	Berlin
Germany	KPPK GmbH, Studienzentrum	Koblenz
Germany	Pneumologiezentrum Leipzig	Leipzig
Germany	Pneumologische Schwerpunktpraxis, 23558 Lübeck	Lübeck
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Franciscus Gasthuis	Rotterdam
Netherlands	Gelre Ziekenhuis Zutphen	Zutphen
Norway	Frisk Utvikling Helse AS	Elverum
Norway	Hisøy Legesenter	Kolbjørnsvik
Norway	Lambertseter Legesenter	Oslo
Norway	Svelvik Legesenter	Svelvik

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  Germany,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
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	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).
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	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.

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