Professional Slides: Patient preference

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Many of the technological advances incorporated into Respimat® SMI were designed to make the device easier to use and handle than other currently available inhalers.Some indication of whether the features of Respimat® SMI make a genuine difference in everyday practice has been provided by analysis of questionnaires designed to measure patient satisfaction with the device.

Questionnaires were administered as post hoc market research to subsets of patients in two Respimat® SMI trials, one in Germany using IB/FEN and one completed in Canada using IB. In the German trial, 47 COPD patients completed questionnaires after receiving 12 weeks’ treatment with IB/FEN via Respimat® SMI. In the Canadian trial, 129 COPD patients completed questionnaires after receiving IB via Respimat® SMI for 6 months.

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In the German trial, 47 patients with COPD completed the patient device satisfaction and preference questionnaire after using Respimat® SMI for 12 weeks.
The patients were asked: "How long did it take you to feel confident in handling Respimat® SMI?"
The majority of patients (76.6%) felt confident in handling Respimat® SMI after using the device for only one day.

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Given the choice between Respimat® SMI and MDI, 85.1% of patients in this trial would prefer to use Respimat® SMI. Handling aspects, convenience of usage and inhalation aspects were frequently mentioned to explain the preference for Respimat® SMI.

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The objective of this multicentre, randomised, double-blind (within-device), placebo- and active-controlled, parallel-group study was to compare the long-term clinical efficacy and safety of IB delivered from the novel, propellant-free Respimat® SMI with that of a conventional CFC-MDI in COPD patients (Hodder et al. 2001).

At the end of the 6-month period, questionnaires were administered to a subset of 129 patients as post hoc market research.

One of the questions asked the patient to rate the overall ease/difficulty in using Respimat® SMI. A total of 126 (97.7%) of patients rated the device as easy or very easy to use and only one patient had difficulty in using the device.

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Patients were asked to rate, on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied), how satisfied they had been with Respimat® SMI over the course of the 6-month study.

The majority of patients (59%) were extremely satisfied with Respimat® SMI and 90% of patients recorded a satisfaction score of 8 or more. The analysis showed the mean score to be 9.1.

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This randomised, double-blind, double-dummy, parallel-group, active-controlled study was designed to establish the clinical efficacy and safety of budesonide delivered via Respimat® SMI or MDPI (Turbuhaler®) over a 12-week period in asthma patients.

While device satisfaction and preference were not the focus of this clinical trial, it offered a unique opportunity to use the questionnaire to compare two inhaler devices, since patients were able to use and evaluate both devices.

After 12 weeks of treatment, a subset of 153 patients (from Germany, South Africa and Canada) were asked to complete a patient device satisfaction and preference questionnaire (all patients in the specified countries were asked to participate).

The questionnaire consisted of 62 items covering various attributes of inhaler devices considered important by patients who regularly use them. Selection of items was based on: (a) a literature review, (b) market research data, and (c) expert opinion. The 62 items were divided into 5 sections, including: satisfaction, confidence, handling the device, importance of inhaler attributes, and preference.

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A total of 153 patients completed assessments of both Respimat® SMI and MDPI (Turbuhaler®); 47 of the patients were from Germany, 55 from South Africa and 51 from Canada. Patients were asked to indicate which inhaler they preferred.

A total of 152 of the patients responded to this question, with 112 (74%) indicating a preference for Respimat® SMI and 26 (17%) indicating a preference for MDPI (Turbuhaler®). Fourteen subjects (9%) indicated no preference for either inhaler.

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Patients were asked to indicate their willingness to continue using each of the devices that they had used during the study on a scale from 0 (not willing to continue) to 100 (definitely willing to continue).

Analysis of the responses to this question showed that the willingness to continue using Respimat® SMI was higher than that for MDPI (Turbuhaler®) (mean scores of 80 and 62, respectively).

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Patients with COPD, asthma or mixed disease were randomised to receive IB/FEN 20/50 µg via Respimat® SMI or 40/100 µg via HFA-MDI for 7 weeks each in a crossover design. Patients were trained in the use of the inhaler at the beginning of each treatment period.

The primary endpoint was the patient’s assessment of inhaler preference at the end of the study after completion of the two treatment periods.

The secondary endpoints were:

(i) ratings of willingness to continue using each inhaler on a scale of 0 to 100
(ii) ratings of inhaler satisfaction from a 15-item patient satisfaction questionnaire
(iii) retention of inhaler technique
(iv) ease of Respimat® SMI assembly
(v) clinical efficacy measures, recorded on a daily diary card (evening PEF, rescue medication use and daytime and night-time symptom scores).
Adverse events were recorded throughout the study.

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Following initial screening, patients entered a 2-week run-in period during which they received IB/FEN via HFA-MDI at the dosage they were taking before entering the study (at least 2 actuations of IB/FEN 20/50 µg tid).

Patients were then randomised to receive IB/FEN delivered via either Respimat® SMI (1 actuation of 20/50 µg tid or qid [according to their regular treatment regime]) or HFA-MDI (2 actuations of 20/50 µg [IB/FEN 40/100 µg] tid or qid) for 7 weeks each in a crossover design (dosage selection was based on clinical study results, which have demonstrated that IB/FEN 20/50 µg via Respimat® SMI is therapeutically equivalent to 40/100 µg via pMDI).

The two treatment periods were not separated by a washout period.

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In total, 245 patients were randomised and 224 used both inhalers within their respective treatment periods.

Of 201 patients expressing a preference, 162 (80.6%) preferred Respimat® SMI and 39 (19.4%) preferred HFA-MDI (p<0.001).

Inhaler preference was unaffected by whether Respimat® SMI was given in treatment period 1 or 2 (Respimat® SMI was preferred by 81.4% of patients using it in treatment period 1 and by 79.8% using it in period 2).

Furthermore, preference was unaffected by age or by trial diagnosis. Of the 44 patients who had concomitant diagnoses that might have adversely affected inhaler handling (e.g. hyperuricaemia/gout, osteoporosis, athrosis/osteoarthritis, eye disorders, or neck, shoulder and arm syndrome), 39 (88.6%) preferred Respimat® SMI to HFA-MDI.

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At the end of the study, patients were asked to rate their willingness to continue using each inhaler on a scale of 0 to 100, where 0 indicated ‘not willing’ and 100 indicated ‘definitely willing’.

Patients were more willing to continue using Respimat® SMI than HFA-MDI (median scores of 85 and 50, respectively; median difference = 30; p<0.001).

Willingness to continue was largely unaffected by whether Respimat® SMI was given in treatment period 1 or 2 (median scores in period 1: Respimat® SMI = 90, HFA-MDI = 50, median difference = 30; period 2: Respimat® SMI = 80, HFA-MDI = 50, median difference = 35).

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At the end of each treatment period, patients were asked to complete a 15-item satisfaction questionnaire featuring a 7-point Likert scale, where 1 indicates ‘very dissatisfied’ and 7 indicates ‘very satisfied’.

The mean score the ’performance’ domain and the total score were significantly higher for Respimat® SMI than for HFA-MDI (p<0.001); the convenience domain did not show a significant difference.

In general, the mean ratings for questions about inhaler satisfaction were between 5.0 and 6.5 for both devices. The mean overall satisfaction rating was 6.2±1.0 for Respimat® SMI and 5.4±1.3 for HFA-MDI (mean difference 0.8±1.7; p<0.001).

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Patients were trained in inhaler use and given ≦5 attempts to demonstrate satisfactory technique. Patients’ technique was judged by the investigator based on 7 different device handling and breathing tasks; the number of tasks correctly performed (out of 7) produced the total score for each attempt.

Retention of inhaler technique was achieved if the patient attained a total score of 7 at the beginning (after ≦5 attempts) and end (after 1 attempt) of a treatment period.

At the beginning of each treatment period, the majority of patients were able to achieve satisfactory inhaler technique at their final attempt (Respimat® SMI: 216 [96.4%]; HFA-MDI: 220 [98.2%]). However, the proportion of patients achieving a score of 7 at the first attempt was higher for HFA-MDI than for Respimat® SMI (180 [80.4%] vs. 108 [48.2%]).

Although patients required more training attempts before they could achieve good technique with Respimat® SMI, 217 (96.9%) patients were judged to have retained good technique with Respimat® SMI after 7 weeks’ use, slightly more than in the HFA-MDI group (210; 93.8%).

There was no statistical analysis of these results.

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During the Respimat® SMI treatment period, patients had to assemble a new device at home. Patients were asked to record the ease of assembly as either ‘easy’, ‘some difficulty’, ‘difficult’ or ‘unable’.

Most patients (89.4%) found Respimat® SMI easy to assemble. Only 1 patient in the entire data set was unable to assemble the device. Of those patients with adverse concomitant diagnoses, 36 (81.8%) reported that Respimat® SMI was easy to assemble.

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The study was not designed to compare the efficacy of the two inhalers, and did not have sufficient statistical power to detect efficacy differences in the sample studied. Clinical efficacy measures were assessed solely to investigate any changes in the efficacy of IB/FEN when patients switched from one inhaler to the other.

Clinical efficacy measures were recorded on a daily diary card (evening PEF, rescue medication use and daytime and night-time symptom scores [daytime: 0–5 scale, where 0 indicated 'no symptoms' and 5 indicated 'severe symptoms'; night-time: 0–4 scale, where 0 indicated 'no symptoms' and 4 indicated 'awake most of the night']).

For all clinical efficacy measures the differences in period means between the Respimat® SMI and HFA-MDI groups were small and not statistically significant; however, weekly least square mean values for symptom scores, rescue medication use and evening PEF were consistently better with Respimat® SMI.

These findings suggest that patients are able to be switched safely from one inhaler to another.

IB/FEN delivered via Respimat® SMI and HFA-MDI was well-tolerated.

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A large majority of patients preferred Respimat® SMI to HFA-MDI.

Patients would rather continue using Respimat® SMI than HFA-MDI.
Mean scores for 13 of the 15 satisfaction questions were significantly higher for Respimat® SMI than HFA-MDI; in addition, the total score was also significantly higher for Respimat® SMI.
Most patients were judged to have good technique with Respimat® SMI after 7 weeks’ use.
Most patients found Respimat® SMI easy to assemble.
Differences in efficacy measures between the devices were not significant.