Clinical trial NCT04011735: Re-usable Respimat® Soft MistTM Inhaler Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 262
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
Secondary outcomes:
measure: Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
measure: Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
measure: Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
measure: Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
measure: Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
measure: 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
timeFrame: At study entry (baseline) and at study end (4 to 6 weeks after baseline).
measure: 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
timeFrame: At follow-up assessment, 4 to 6 weeks after baseline.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Brussels - UNIV UZ Brussel
city: Gosselies
country: Belgium
facility: Clinique Notre-Dame de Grâce
city: Menen
country: Belgium
facility: Roeselare - HOSP AZ Delta
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Turku
country: Finland
facility: TYKS, Keuhkosairauksien klinikka, Turku
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Berlin
country: Germany
facility: MECS Research GmbH, Berlin
city: Koblenz
country: Germany
facility: KPPK GmbH, Studienzentrum
city: Leipzig
country: Germany
facility: Pneumologiezentrum Leipzig
city: Lübeck
country: Germany
facility: Pneumologische Schwerpunktpraxis, 23558 Lübeck
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuis Zutphen
city: Elverum
country: Norway
facility: Frisk Utvikling Helse AS
city: Kolbjørnsvik
country: Norway
facility: Hisøy Legesenter
city: Oslo
country: Norway
facility: Lambertseter Legesenter
city: Svelvik
country: Norway
facility: Svelvik Legesenter
Study officials:
References: