| Literature DB >> 27013871 |
Marc Miravitlles1, Jéssica Montero-Caballero2, Frank Richard2, Salud Santos3, Juan Luis Garcia-Rivero4, Francisco Ortega5, Xavier Ribera6.
Abstract
Delivery of inhaled medications via an inhaler device underpins the effectiveness of treatment for patients with chronic obstructive pulmonary disease (COPD). Correct inhaler technique among patients is also a predictor of achieving treatment compliance and adherence. Reporting of patient satisfaction with inhalers is therefore gaining increasing attention and is now recognized as an important patient-reported outcome in clinical trials involving patients with COPD or asthma. In this cross-sectional study, we use the validated Patient Satisfaction and Preference Questionnaire (PASAPQ) to assess the handling and satisfaction for Respimat(®) Soft Mist™ Inhaler (SMI) compared with the Breezhaler(®) dry powder inhaler (DPI) among patients with COPD in Spain. Patients were already assigned to therapy with either SPIRIVA(®) (tiotropium) Respimat(®) or with Hirobriz(®)/Onbrez(®)/Oslif(®) (indacaterol) Breezhaler(®) for at least 3 but not more than 6 months before completing the PASAPQ at a single visit to the study site. The primary endpoint of the trial was the mean total PASAPQ score. Secondary endpoints were the performance score domain of the PASAPQ, the convenience score domain of the PASAPQ, and the overall satisfaction score of the PASAPQ. For the primary endpoint, the mean PASAPQ total score in the Respimat(®) and Breezhaler(®) groups was 80.7 and 79.9, respectively (difference of 0.8, 95% confidence interval [CI] -2.9 to 4.5; P=0.67). The mean total performance scores were 82.5 and 78.2 (difference of 4.3, 95% CI -0.3 to 8.9; P=0.06), and the mean total convenience scores were 78.6 and 81.9 (difference of -3.3, 95% CI -7.0 to 0.4; P=0.08) for the Respimat(®) and Breezhaler(®) groups, respectively. Patients gave the Respimat(®) SMI and the Breezhaler(®) DPI overall satisfaction PASAPQ scores of 6.0 and 5.9, respectively, which shows that patients were satisfied with these inhalers.Entities:
Keywords: Breezhaler®; COPD; Respimat®; handling; inhaler
Mesh:
Substances:
Year: 2016 PMID: 27013871 PMCID: PMC4777273 DOI: 10.2147/COPD.S91118
Source DB: PubMed Journal: Int J Chron Obstruct Pulmon Dis ISSN: 1176-9106
Baseline characteristics of patients
| Respimat® (n=77) | Breezhaler® (n=77) | Total (N=154) | ||
|---|---|---|---|---|
| Age – mean (SD) | 69.7 (10.0) | 67.0 (9.9) | 68.4 (10.0) | 0.102 |
| Male – n (%) | 69 (89.6) | 70 (90.9) | 139 (90.3) | 0.786 |
| BMI – n (%) | 0.063 | |||
| <18 kg/m2 | 1 (1.3) | 1 (1.3) | 2 (1.3) | |
| 18 to ≤30 kg/m2 | 48 (62.3) | 51 (66.2) | 99 (64.3) | |
| >30 kg/m2 | 27 (35.1) | 25 (32.5) | 52 (33.8) | |
| Smoking status – n (%) | 0.496 | |||
| Current smoker | 18 (23.4) | 15 (19.5) | 33 (21.4) | |
| Ex-smokers | 55 (71.4) | 60 (77.9) | 115 (74.7) | |
| Pack-years of smoking – mean (SD) | 57.9 (26.2) | 55.7 (24.7) | 56.8 (25.4) | 0.605 |
| Time since COPD diagnosis, years – (SD) | 6.3 (6.0) | 5.9 (5.4) | 6.1 (5.7) | 0.643 |
| Postbronchodilation spirometry – mean (SD) | ||||
| FEV1 – liters | 1.5 (0.6) | 1.6 (0.7) | 1.6 (0.6) | 0.214 |
| FEV1 – % of predicted value | 55.1 (16.5) | 56.5 (21.5) | 55.8 (19.1) | 0.652 |
| FVC – liters | 2.8 (0.8) | 3.1 (0.9) | 3.0 (0.9) | 0.035 |
| FVC – % of predicted value | 76.2 (16.7) | 81.7 (23.4) | 78.9 (20.4) | 0.098 |
| FEV1/FVC | 53.9 (12.9) | 51.8 (12.2) | 52.9 (12.5) | 0.304 |
| Respiratory medication – n (%) | ||||
| Inhaled anticholinergics | ||||
| Long-acting | ||||
| SPIRIVA® Respimat® | 77 (100) | 0 (0.0) | 77 (50.0) | |
| Short-acting | 8 (10.4) | 13 (16.9) | 21 (13.6) | 0.240 |
| Inhaled β-agonists | ||||
| Long-acting | ||||
| Hirobriz® Breezhaler® | 0 (0.0) | 16 (20.8) | 16 (10.4) | |
| Onbrez® Breezhaler® | 0 (0.0) | 51 (66.2) | 51 (33.1) | |
| Oslif® Breezhaler® | 0 (0.0) | 10 (13.0) | 10 (6.5) | |
| Short-acting | 46 (59.7) | 43 (55.8) | 89 (57.8) | 0.624 |
| Corticosteroids | ||||
| Inhaled | 52 (67.5) | 22 (28.6) | 74 (48.1) | <0.001 |
| Systemic | 3 (3.9) | 3 (3.9) | 6 (3.9) | 1.000 |
| Theophylline | 0 (0.0) | 2 (2.6) | 2 (1.3) | 0.497 |
| Received training on inhalation technique at initial prescription – n (%) | 73 (94.8) | 76 (98.7) | 149 (96.8) | 0.367 |
| Instructions given by – n (%) | ||||
| Doctor | 51 (69.9) | 42 (55.3) | 93 (62.4) | |
| Nurse | 18 (24.7) | 34 (44.7) | 52 (34.9) | |
| Pharmacist | 2 (2.7) | 0 (0.0) | 2 (1.3) | |
| Other | 1 (1.4) | 0 (0.0) | 1 (0.7) | |
| Missing | 1 (1.4) | 0 (0.0) | 1 (0.7) | |
Note: P-values are based on chi-square test or Fisher’s exact test for the categorical variables, and on a two-sample t-test for the continuous variables.
Abbreviations: BMI, body mass index; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC1, forced vital capacity; SD, standard deviation.
Figure 1Mean PASAPQ scores by treatment.
Abbreviations: PASAPQ, Patient Satisfaction and Preference Questionnaire; SD, standard deviation.
PASAPQ scores by treatment
| PASAPQ scores | Respimat® (n=77) | Breezhaler® (n=77) | Mean difference (95% CI) | |
|---|---|---|---|---|
| Total score | 80.7 (10.5) | 79.9 (12.7) | 0.8 (−2.9 to 4.5) | 0.67 |
| Total performance | 82.5 (12.6) | 78.2 (15.8) | 4.3 (−0.3 to 8.9) | 0.06 |
| Total convenience | 78.6 (11.3) | 81.9 (11.7) | −3.3 (−7.0 to 0.4) | 0.08 |
| Overall satisfaction | 6.0 (0.8) | 5.9 (1.2) | 0.1 (−0.3 to 0.4) | 0.70 |
Note: Data are mean (SD) unless otherwise specified.
Abbreviations: CI, confidence interval; PASAPQ, Patient Satisfaction and Preference Questionnaire; SD, standard deviation.
Figure 2Distribution of total PASAPQ scores.
Abbreviation: PASAPQ, Patient Satisfaction and Preference Questionnaire.
PASAPQ scores stratified by age groups
| PASAPQ scores | Age groups
| ||
|---|---|---|---|
| ≤70 years | >70 years | ||
| Total score | |||
| Respimat® | 80.1 (12.4) | 81.3 (8.2) | 0.62 |
| Breezhaler® | 81.8 (11.2) | 77.1 (14.4) | 0.11 |
| Total performance | |||
| Respimat® | 81.0 (15.4) | 84.0 (8.7) | 0.30 |
| Breezhaler® | 80.7 (13.4) | 74.5 (18.5) | 0.09 |
| Total convenience | |||
| Respimat® | 79.1 (12.7) | 78.1 (9.8) | 0.72 |
| Breezhaler® | 83.1 (10.8) | 80.2 (13.1) | 0.29 |
| Overall satisfaction | |||
| Respimat® | 6.0 (1.0) | 6.0 (0.6) | 0.88 |
| Breezhaler® | 6.1 (1.2) | 5.6 (1.2) | 0.04 |
Note: Data are mean (SD) unless otherwise specified.
Abbreviations: PASAPQ, Patient Satisfaction and Preference Questionnaire; SD, standard deviation.
PASAPQ scores stratified by smoking status
| PASAPQ scores | Smoking status
| ||
|---|---|---|---|
| Current smoker | Ex-smoker | ||
| Total score | |||
| Respimat® | 82.8 (11.5) | 79.8 (10.4) | 0.30 |
| Breezhaler® | 76.1 (10.7) | 80.8 (13.1) | 0.20 |
| Total performance | |||
| Respimat® | 82.7 (14.1) | 82.2 (12.5) | 0.89 |
| Breezhaler® | 73.8 (13.7) | 79.3 (16.2) | 0.23 |
| Total convenience | |||
| Respimat® | 83.0 (10.7) | 77.1 (11.5) | 0.06 |
| Breezhaler® | 78.7 (11.5) | 82.5 (11.9) | 0.27 |
| Overall satisfaction | |||
| Respimat® | 6.2 (0.9) | 5.9 (0.8) | 0.19 |
| Breezhaler® | 5.3 (1.7) | 6.1 (1.0) | 0.02 |
Note: Data are mean (SD) unless otherwise specified.
Abbreviations: PASAPQ, Patient Satisfaction and Preference Questionnaire; SD, standard deviation.
PASAPQ scores stratified by time since diagnosis of COPD
| PASAPQ scores | Time since COPD diagnosis
| ||
|---|---|---|---|
| ≤6 years | >6 years | ||
| Total score | |||
| Respimat® | 79.6 (12.3) | 82.3 (6.9) | 0.28 |
| Breezhaler® | 80.0 (12.8) | 79.9 (12.7) | 0.98 |
| Total performance | |||
| Respimat® | 80.5 (14.8) | 85.5 (7.6) | 0.09 |
| Breezhaler® | 78.2 (15.4) | 78.2 (16.8) | 0.99 |
| Total convenience | |||
| Respimat® | 78.7 (13.0) | 78.6 (8.4) | 0.98 |
| Breezhaler® | 82.0 (12.3) | 81.9 (11.1) | 0.96 |
| Overall satisfaction | |||
| Respimat® | 5.9 (1.0) | 6.0 (0.5) | 0.73 |
| Breezhaler® | 5.8 (1.3) | 6.0 (1.0) | 0.43 |
Note: Data are mean (SD) unless otherwise specified.
Abbreviations: COPD, chronic obstructive pulmonary disease; PASAPQ, Patient Satisfaction and Preference Questionnaire; SD, standard deviation.
Validated questions included in the modified PASAPQ
| Domain | Question | Description |
|---|---|---|
| Total score | ||
| Performance domain | Q1 | Overall feeling of inhaling |
| Q2 | Inhaled dose goes to lungs | |
| Q3 | Amount of medication left | |
| Q4 | Works reliably | |
| Q5 | Ease of inhaling a dose | |
| Q10 | Using the inhaler | |
| Q11 | Speed medicine comes out | |
| Convenience domain | Q6 | Instructions for use |
| Q7 | Size of inhaler | |
| Q8 | Durability of inhaler | |
| Q9 | Ease of cleaning inhaler | |
| Q12 | Ease of holding during use | |
| Q13 | Convenience of carrying | |
| Q14 | Overall satisfaction | |
Notes: All items scored on a 7-point Likert scale: 1= very dissatisfied, 2= dissatisfied, 3= somewhat dissatisfied, 4= neither satisfied nor dissatisfied, 5= somewhat satisfied, 6= satisfied, 7= very satisfied.
Abbreviation: PASAPQ, Patient Satisfaction and Preference Questionnaire.