Trial Outcomes & Findings for Preference Tiotropium Respimat Study in COPD (NCT NCT01810692)
NCT ID: NCT01810692
Last Updated: 2015-03-26
Results Overview
Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
COMPLETED
150 participants
day 1
2015-03-26
Participant Flow
Participant milestones
| Measure |
Spiriva Respimat
Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preference Tiotropium Respimat Study in COPD
Baseline characteristics by cohort
| Measure |
Spiriva Respimat
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
67.0 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
68.4 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Time since diagnosis of COPD
|
6.3 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
5.9 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
6.1 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: day 1Population: Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.
Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
Outcome measures
| Measure |
Spiriva Respimat
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
|---|---|---|
|
Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)
|
80.71 units on a scale
Standard Deviation 10.47
|
79.92 units on a scale
Standard Deviation 12.68
|
SECONDARY outcome
Timeframe: day 1Population: Patients from FAS.
All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
Outcome measures
| Measure |
Spiriva Respimat
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
|---|---|---|
|
Total Performance PASAPQ Score.
|
82.50 units on a scale
Standard Deviation 12.57
|
78.20 units on a scale
Standard Deviation 15.84
|
SECONDARY outcome
Timeframe: day 1Population: Patients from FAS.
All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
Outcome measures
| Measure |
Spiriva Respimat
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
|---|---|---|
|
Total Convenience PASAPQ Score
|
78.62 units on a scale
Standard Deviation 11.28
|
81.93 units on a scale
Standard Deviation 11.74
|
SECONDARY outcome
Timeframe: day 1Population: Patients from FAS
The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.
Outcome measures
| Measure |
Spiriva Respimat
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
|
Hirobriz/Onbrez/Oslif Breezhaler
n=77 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
|
|---|---|---|
|
Overall Satisfaction Question
|
5.96 units on a scale
Standard Deviation 0.80
|
5.90 units on a scale
Standard Deviation 1.21
|
Adverse Events
Spiriva Respimat
Hirobriz/Onbrez/Oslif Breezhaler
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Other - 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