Pulmonary Disease, Chronic ObstructiveNCT04011735
Re-usable Respimat® Soft MistTM Inhaler Study
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 20 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Respimat
- How many people
- 262 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 30 Sep 2019to 13 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Germany5 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
MECS Research GmbH, Berlin
Berlin, 12203
KPPK GmbH, Studienzentrum
Koblenz, 56068
Pneumologiezentrum Leipzig
Leipzig, 04207
Pneumologische Schwerpunktpraxis, 23558 Lübeck
Lübeck, 23558
Netherlands5 sites
Amphia Ziekenhuis
Breda, 4818 CK
Zuyderland Medisch Centrum
Heerlen, 6419 PC
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Franciscus Gasthuis
Rotterdam, 3045 PM
Gelre Ziekenhuis Zutphen
Zutphen, 7207 AE
Norway4 sites
Frisk Utvikling Helse AS
Elverum, N-2402
Hisøy Legesenter
Kolbjørnsvik, N-4816
Lambertseter Legesenter
Oslo, N-1157
Svelvik Legesenter
Svelvik, N-3060
Belgium3 sites
Brussels - UNIV UZ Brussel
Brussels, 1090
Clinique Notre-Dame de Grâce
Gosselies, 6041
Roeselare - HOSP AZ Delta
Menen, 8930
About this 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.
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Respimat
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespimatDrug
Also called (Spiriva®, Striverdi® or, Spiolto®)
Soft Mist Inhaler product
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Respimat | |
| Respimat SMI-naïve | patients who have not previously used a Respimat SMI product and receive their first prescription at study entry Receives: Drug: Respimat | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: At follow-up assessment, 4 to 6 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start30 Sep 2019
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011735
- Sponsor's protocol ID
- 1237-0097
- Status last verified
- Feb 2021
- First submitted
- 4 Jul 2019
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04011735
- Acronym / sponsor ID
- 1237-0097
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Respimat SMI-experienced: Switching to re-usable Respimat | – | Drug: Respimatpatients 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 | – | Drug: Respimatpatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespimatAlso: (Spiriva®, Striverdi® or, Spiolto®)Soft Mist Inhaler product | Drug | Respimat SMI-experienced: Switching to re-usable Respimat, Respimat SMI-naïve |
Primary outcome
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)
7 secondary outcomes
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.
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.
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.
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.
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.
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Netherlands, Norway, Belgium, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score (time frame: At follow-up assessment, 4 to 6 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.