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Completed

NCT Number: NCT04011735

Re-usable Respimat® Soft MistTM Inhaler Study

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brussels - UNIV UZ Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respimat

Drug

Soft Mist Inhaler product

Other names: (Spiriva®, Striverdi® or, Spiolto®)

Primary outcomes

  1. Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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)

Secondary outcomes

  1. Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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)

  2. Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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)

  3. Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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.

  4. Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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.

  5. Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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.

  6. 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

    Time frame: At study entry (baseline) and at study end (4 to 6 weeks after baseline).

    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.

  7. 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

    Time frame: At follow-up assessment, 4 to 6 weeks after baseline.

    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?"

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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