Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
In COPD the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for COPD. This is a cross-sectional study where satisfaction, preference and handling of two different devices such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD patients
Detailed description
Purpose: Study Design:
Interventions
DEVICEGroup1:Spiriva® Respimat®
COPD patients using Respimat®
DEVICEGroup2:Hirobriz®/Oslif®/Onbrez® Breezhaler®
COPD patients using Breezhaler®®
Sponsors
Boehringer Ingelheim
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the study and conducting any study procedures. 2. Adult male or female patients with chronic obstructive pulmonary disease (COPD) for less than a year who follow usual clinical practice of the participant sites and who are on treatment with Spiriva® Respimat®, Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler® for at least of 3 months but not more than maximum of 6 months before the informed consent date.
Exclusion criteria
1. Previously included in this study or currently participating in another interventional study. 2. Visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire. 3. Patients who are treated simultaneously with both respiratory medications (Spiriva® Respimat® and Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) | day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Performance PASAPQ Score. | day 1 | 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. |
| Total Convenience PASAPQ Score | day 1 | 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. |
| Overall Satisfaction Question | day 1 | The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spiriva Respimat Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation. | 77 |
| Hirobriz/Onbrez/Oslif Breezhaler Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation. | 77 |
| Total | 154 |
Baseline characteristics
| Characteristic | Spiriva Respimat | Hirobriz/Onbrez/Oslif Breezhaler | Total |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 10 | 67.0 years STANDARD_DEVIATION 9.9 | 68.4 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 69 Participants | 70 Participants | 139 Participants |
| Time since diagnosis of COPD | 6.3 years STANDARD_DEVIATION 6 | 5.9 years STANDARD_DEVIATION 5.4 | 6.1 years STANDARD_DEVIATION 5.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (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.
Time frame: day 1
Population: Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva Respimat | Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) | 80.71 units on a scale | Standard Deviation 10.47 |
| Hirobriz/Onbrez/Oslif Breezhaler | Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) | 79.92 units on a scale | Standard Deviation 12.68 |
Secondary
Overall Satisfaction Question
The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.
Time frame: day 1
Population: Patients from FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva Respimat | Overall Satisfaction Question | 5.96 units on a scale | Standard Deviation 0.8 |
| Hirobriz/Onbrez/Oslif Breezhaler | Overall Satisfaction Question | 5.90 units on a scale | Standard Deviation 1.21 |
Secondary
Total Convenience PASAPQ Score
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.
Time frame: day 1
Population: Patients from FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva Respimat | Total Convenience PASAPQ Score | 78.62 units on a scale | Standard Deviation 11.28 |
| Hirobriz/Onbrez/Oslif Breezhaler | Total Convenience PASAPQ Score | 81.93 units on a scale | Standard Deviation 11.74 |
Secondary
Total Performance PASAPQ Score.
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.
Time frame: day 1
Population: Patients from FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva Respimat | Total Performance PASAPQ Score. | 82.50 units on a scale | Standard Deviation 12.57 |
| Hirobriz/Onbrez/Oslif Breezhaler | Total Performance PASAPQ Score. | 78.20 units on a scale | Standard Deviation 15.84 |