Trial Outcomes & Findings for Re-usable Respimat® Soft MistTM Inhaler Study (NCT NCT04011735)
NCT ID: NCT04011735
Last Updated: 2021-03-03
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
262 participants
Primary outcome timeframe
At follow-up assessment, 4 to 6 weeks after baseline.
Results posted on
2021-03-03
Participant Flow
A real-world, non-interventional study to assess the satisfaction of chronic obstructive pulmonary disease (COPD) patients with inhaler attributes and preferences for re-usable Respimat® Soft Mist Inhaler (SMI).
262 patients were enrolled into the study, whereof 2 patients were enrolment failures as they did not meet eligibility criteria or received a disposable inhaler. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
71
|
56
|
|
Overall Study
COMPLETED
|
132
|
70
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Met exclusion criteria after study entry
|
0
|
1
|
0
|
Baseline Characteristics
Re-usable Respimat® Soft MistTM Inhaler Study
Baseline characteristics by cohort
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=133 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=70 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=56 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.1 Years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
68.6 Years
STANDARD_DEVIATION 8.58 • n=7 Participants
|
68.7 Years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
68.9 Years
STANDARD_DEVIATION 7.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Patients in the Full Analysis Set (FAS) who have available data for this endpoint.
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)
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=131 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=55 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score
|
84.26 Score on a scale
Interval 82.69 to 85.82
|
81.59 Score on a scale
Interval 78.71 to 84.47
|
83.24 Score on a scale
Interval 79.89 to 86.59
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Patients in the Full Analysis Set (FAS) who have available data for this endpoint.
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)
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=131 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=55 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)
|
84.70 Score on a scale
Standard Deviation 12.647
|
82.88 Score on a scale
Standard Deviation 14.938
|
82.38 Score on a scale
Standard Deviation 16.288
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Patients in the Full Analysis Set (FAS) who have available data for this endpoint.
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)
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=131 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=55 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)
|
83.74 Score on a scale
Standard Deviation 10.799
|
80.08 Score on a scale
Standard Deviation 15.075
|
84.24 Score on a scale
Standard Deviation 14.434
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Patients in the Full Analysis Set (FAS) who have available data for this endpoint.
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.
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=131 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=55 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Very dissatisfied
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Dissatisfied
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Somewhat dissatisfied
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Neither satisfied nor dissatisfied
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Somewhat satisfied
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Satisfied
|
69 Participants
|
36 Participants
|
25 Participants
|
|
Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)
Very Satisified
|
49 Participants
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Patients in the Full Analysis Set (FAS) who have available data for this endpoint.
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.
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=131 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=54 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)
|
89.1 Score on a scale
Standard Deviation 19.23
|
88.0 Score on a scale
Standard Deviation 19.29
|
84.1 Score on a scale
Standard Deviation 22.98
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: Full Analysis Set (FAS): All enrolled patients who met all the eligibility criteria of this study and who had received at least one dose of their re-usable Respimat SMI product during the study. Missing patients did not perform the Follow-up assesment or who did not perform the Ease of Handling assessment at 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.
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=130 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
n=69 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
n=55 Participants
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Neither satisfied nor dissatisfied
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Somewhat satisfied
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Very dissatisfied
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Somewhat dissatisfied
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Dissatisfied
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Somewhat dissatisfied
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Dissatisfied
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Very satisfied
|
56 Participants
|
20 Participants
|
22 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Neither satisfied nor dissatisfied
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Somewhat satisfied
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Satisfied
|
54 Participants
|
39 Participants
|
26 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Not applicable
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Very dissatisfied
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Dissatisfied
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Somewhat dissatisfied
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Satisfied
|
64 Participants
|
29 Participants
|
26 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Very satisfied
|
49 Participants
|
21 Participants
|
21 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q1: How satisfied are you with the ease of removing the clear base? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Dissatisfied
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Somewhat dissatisfied
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Neither satisfied nor dissatisfied
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Somewhat satisfied
|
6 Participants
|
1 Participants
|
4 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Satisfied
|
66 Participants
|
38 Participants
|
31 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Very satisfied
|
51 Participants
|
23 Participants
|
17 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q2: How satisfied are you with the grip of the cartridge? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Very dissatisfied
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Dissatisfied
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Somewhat dissatisfied
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Neither satisfied nor dissatisfied
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Somewhat satisfied
|
10 Participants
|
6 Participants
|
5 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Satisfied
|
57 Participants
|
31 Participants
|
30 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Very satisfied
|
47 Participants
|
17 Participants
|
14 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q3: How satisfied are you with inserting a new cartridge? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Very dissatisfied
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Dissatisfied
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Somewhat dissatisfied
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Neither satisfied nor dissatisfied
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Somewhat satisfied
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Satisfied
|
62 Participants
|
27 Participants
|
34 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Very satisfied
|
53 Participants
|
35 Participants
|
15 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q4: How satisfied are you with the readability of the dose indicator? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Very dissatisfied
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Dissatisfied
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Neither satisfied nor dissatisfied
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Somewhat satisfied
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Satisfied
|
65 Participants
|
35 Participants
|
33 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Very satisfied
|
52 Participants
|
28 Participants
|
15 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q5: How satisfied are you with recognising when you need to replace the cartridge? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Very dissatisfied
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Dissatisfied
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Somewhat dissatisfied
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Neither satisfied nor dissatisfied
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Somewhat satisfied
|
10 Participants
|
5 Participants
|
5 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Satisfied
|
65 Participants
|
31 Participants
|
33 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Very satisfied
|
43 Participants
|
19 Participants
|
13 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Very dissatisfied
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Dissatisfied
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Somewhat dissatisfied
|
4 Participants
|
7 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Neither satisfied nor dissatisfied
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Somewhat satisfied
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Satisfied
|
69 Participants
|
35 Participants
|
30 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Very satisfied
|
41 Participants
|
15 Participants
|
17 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q7: How satisfied are you with automatic return to start-use position when replacing the clear base? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Very dissatisfied
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Neither satisfied nor dissatisfied
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Somewhat satisfied
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Satisfied
|
69 Participants
|
35 Participants
|
27 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Very satisfied
|
54 Participants
|
25 Participants
|
22 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q8: How satisfied are you with the overall ease of handling the inhaler? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Very dissatisfied
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Dissatisfied
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Somewhat dissatisfied
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Neither satisfied nor dissatisfied
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Somewhat satisfied
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Satisfied
|
49 Participants
|
26 Participants
|
26 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Very satisfied
|
67 Participants
|
33 Participants
|
22 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability? · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Very dissatisfied
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)
Q10: How satisfied are you with recognising when to replace the inhaler? · Somewhat dissatisfied
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At study entry (baseline) and at study end (4 to 6 weeks after baseline).Population: FAS: Respimat SMI-experience patients who switched from a disposable to a re-usable Respimat SMI product at study entry and with available data for this endpoint.
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.
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=68 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
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
|
1.10 Score on a scale
Standard Deviation 10.034
|
—
|
—
|
SECONDARY outcome
Timeframe: At follow-up assessment, 4 to 6 weeks after baseline.Population: FAS: Respimat SMI-experience patients who switched from a disposable to a re-usable Respimat SMI product at study entry and with available data for this endpoint.
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?"
Outcome measures
| Measure |
Respimat® SMI-experienced: Maintenance With Re-usable SMI
n=68 Participants
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-experienced: Switching to Re-usable SMI
Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
Respimat® SMI-naïve
Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
|
|---|---|---|---|
|
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
Re-usable inhaler
|
57 Participants
|
—
|
—
|
|
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
Disposable inhaler
|
8 Participants
|
—
|
—
|
|
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
No preference
|
3 Participants
|
—
|
—
|
Adverse Events
Respimat® SMI-experienced: Maintenance With Re-usable SMI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Respimat® SMI-experienced: Switching to Re-usable SMI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Respimat® SMI-naïve
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review Prior to any Submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI´s intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER