|Year : 2014 | Volume
| Issue : 4 | Page : 366-374
Ease-of-use, preference, confidence, and satisfaction with Revolizer ® , a novel dry powder inhaler, in an Indian population
Sujeet K Rajan1, Jaideep A Gogtay2
1 Department of Chest Medicine, Bhatia Hospital and Bombay Hospital and Medical Research Centre, Mumbai, Maharashtra, India
2 Chief Medical Officer, Department of Medical Services, Cipla Limited, Mumbai, Maharashtra, India
|Date of Web Publication||1-Oct-2014|
Dr. Sujeet K Rajan
Ground floor, G-2 Clinic, Department of Chest Medicine, Bhatia Hospital, Mumbai - 400 007, Maharashtra
Source of Support: Cipla Limited,, Conflict of Interest: SKR has received consulting fees for lectures from Cipla Limited, GlaxoSmithKline, and Boehringer Ingelheim in the past. JAG is an employee of Cipla Limited.
Clinical trial registration CTRI number: CTRI/2009/091/000215)
| Abstract|| |
Context: While prescribing an inhaler device, it is important to take into account the usability, preference, confidence, and satisfaction of the patients. Aims: The present study assessed these parameters with Revolizer ® , a novel dry powder inhaler (DPI), in patients with obstructive airway diseases and in device-naïve healthy participants. Settings and Design: In this open-label, prospective, multicentre study with 100 participants [n = 50 healthy participants, n = 45 mild asthma patients, and n = 5 mild chronic obstructive pulmonary disease (COPD) patients], all participants were instructed and trained on the use of Revolizer and then the participants subsequently demonstrated the inhalation technique at two visits. Materials and Methods: The average time required to execute three correct consecutive attempts and the number of errors (including critical errors) were recorded. Participants were asked about the ease of use, preference, confidence, and satisfaction by means of a questionnaire at each visit. Results: The average time required by the participants to achieve three correct consecutive attempts at visit 1 was 3.75 ± 2.10 min, which significantly reduced at visit 2 (3.07 ± 1.32 min, P < 0.01). The number of errors decreased from visit 1 to visit 2. More than 85% participants found the Revolizer easy to use, and it was preferred by more than 75% participants. Revolizer scored high on the confidence and satisfaction of all participants at both visits. Conclusions: Revolizer is an easy-to-use and a preferred device in patients with mild asthma and COPD, as well as in healthy participants with no previous experience of using inhalation devices. The participants felt confident and satisfied using the Revolizer.
Keywords: Asthma, chronic obstructive pulmonary disease, dry powder inhalers, patient preference, Revolizer
|How to cite this article:|
Rajan SK, Gogtay JA. Ease-of-use, preference, confidence, and satisfaction with Revolizer ® , a novel dry powder inhaler, in an Indian population. Lung India 2014;31:366-74
|How to cite this URL:|
Rajan SK, Gogtay JA. Ease-of-use, preference, confidence, and satisfaction with Revolizer ® , a novel dry powder inhaler, in an Indian population. Lung India [serial online] 2014 [cited 2020 May 31];31:366-74. Available from: http://www.lungindia.com/text.asp?2014/31/4/366/142122
| Introduction|| |
Administering drugs through the inhalation route is the most efficacious form of drug delivery in obstructive airway diseases (OADs) such as asthma and chronic obstructive pulmonary disease (COPD).  In addition to being environmental-friendly and requiring minimum maintenance, the key aspects of an ideal inhalation drug delivery system include ease of use, reproducible dosing with optimal drug deposition, and a feedback mechanism to ensure correct dosing. 
Dry powder inhalers (DPIs) are one of the most preferred inhalation drug delivery systems. Their advantages of being breath-actuated, easy to use, and compact make the DPIs reasonably well accepted by patients and their prescribers. ,
The two important factors that should be considered when prescribing an inhalation device are ease of use and patient preference, as these adversely impact a patient's adherence to prescribed therapy, possibly resulting in poor disease control and deteriorating quality of life.  The confidence and satisfaction with the inhaler device will improve patient acceptance towards the device and the therapy and may improve the treatment outcomes, potentially reducing the healthcare costs associated with uncontrolled disease. ,
There are various DPIs now available, and several studies document the safety and efficacy of these DPIs in OADs.  However, few studies have evaluated the ease of use, satisfaction, confidence, and patient preference with DPIs, ,,, though these factors are associated with compliance and, therefore, efficacy.
Revolizer ® is a novel unit dose DPI device having adequate drug deposition  and a simple inhalation technique, allowing patients to confirm dose delivery as they can see, hear, and taste the drug. This is the first study to assess the usability, confidence, satisfaction, and patient preference with Revolizer in healthy volunteers and in patients with asthma and COPD in India.
| Materials and Methods|| |
Study design and methods
This was an open-label, prospective, multicentre study assessing the usability, preference, confidence, and satisfaction with Revolizer in healthy volunteers and in patients with asthma and COPD. Each participant enrolled in one of the two study centers had to complete two study visits. During visit 1 (Day 1), the investigator explained and demonstrated the inhalation technique of Revolizer and noted the time taken by the participants to achieve three consecutive correct attempts. At visit 2 (Day 4), the participants demonstrated the inhalation technique without retraining and the number and types of errors were noted. Irrespective of whether the technique was performed correctly or incorrectly, the participants were trained twice and the time taken to perform three consecutive correct attempts and the number and types of errors noted. At both visits, the participants were asked about the ease of use, preference, confidence, and satisfaction with Revolizer using a questionnaire adapted from Schulte et al. The questionnaire was self-administered with 20 questions divided into four domains of usability, preference, confidence, and satisfaction [Appendix 1] [Additional file 1]. The questionnaire was based on a Likert scale where the responses for usability, preference, and confidence ranged from 1 to 6 and for satisfaction ranged from 1 to 5 (a score of 6 or 5 implied a positive response and a score of 1 implied a negative response). Revolizer is a novel unit dose DPI developed, manufactured, and marketed by Cipla Limited in India. It is a simple-to-use device and consists of a mouthpiece, capsule chamber, and base [Figure 1].
The study included healthy volunteers and patients of asthma and COPD above 18 years of age [Figure 2]. As the questionnaire had been developed in English, participants were included in the study only if they were able to speak and write English. Participants with either mental or physical impairment (such as Parkinson's disease, tremors) were excluded.
The primary endpoint was the average (±SD) time in minutes taken by the participants at visit 1 and visit 2 for three consecutive correct attempts in using the Revolizer. Correct attempt was defined as demonstration of all the steps involved in the proper use of the Revolizer [Appendix 2] [Additional file 2].
The secondary endpoints included the average (±SD) number of attempts required for the first correct attempt and the number and type of errors while using the inhaler device during both the visits. The errors were classified as critical errors - those that can have a significant effect on the drug delivery to the lungs (they include slow inhalation and not holding breath after inhalation) or non-critical errors - those that do not affect dose delivery to the lungs . These errors were classified as being critical or non-critical prior to the study by an expert committee which included the principal investigators, and were not revealed to the participant [Appendix 3] [Additional file 3].
The other secondary endpoints included the average (±SD) number and type of errors without retraining at visit 2, assessment of usability , preference assessment in patients using other devices prior to study enrollment, and an assessment of overall participant response to qualitative attributes, confidence, and satisfaction with the Revolizer.
The study was performed in accordance with the Good Clinical Practices and Declaration of Helsinki and was registered with the Clinical Trials Registry of India (CTRI number: CTRI/2009/091/000215). Ethics committee approval was obtained prior to the initiation of the study. The participants were explained the purpose of the study and the study procedures and a written informed consent was obtained. The device and study sponsorship was provided by Cipla Limited, India. Data management and statistical analysis were performed by an independent agency.
The demographic and baseline characteristics were analyzed and presented descriptively. All categorical variables were presented as counts and percentages. The primary and secondary endpoint of the number of attempts required to achieve first correct attempt was analyzed using paired t-test at 5% level of significance. The other secondary endpoints were described in terms of frequency and percentage of each event, and the mean difference was compared between the two visits.
| Results|| |
Baseline and demographic characteristics
One hundred participants (46 males and 54 females; mean age ± SD = 42 ± 14 years) were screened and enrolled. They consisted of 50 healthy volunteers, 45 patients with mild asthma, and 5 patients with mild COPD (based on the clinical diagnosis), and all completed the study. All patients with asthma and COPD (except two) were experienced in using an inhalation device other than the Revolizer (DPIs, n = 43; pressurized metered-dose inhaler (pMDI) alone, n = 3; and pMDI + spacer, n = 2), whereas all healthy volunteers (and two patients) did not have experience of using any inhalation device [Table 1].
The average (±SD) time taken for three consecutive correct attempts was 3.75 (±2.10) min at visit 1 and 3.07 (±1.32) min at visit 2 (P < 0.01) [Figure 3]. The time taken for three consecutive correct attempts by the healthy participants was 4.07 (±2.34) min at visit 1 and 3.20 (±1.32) min (P = 0.004) at visit 2 [Figure 3]. In patients with asthma or COPD, the average time taken for three consecutive correct attempts was 3.44 (±1.81) min at visit 1 and 2.95 (±1.33) min at visit 2 (P = 0.018) [Figure 3].
|Figure 3: Time taken by participants for three consecutive correct attempts|
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Number of attempts required for correct attempt
The mean (±SD) number of attempts required for the first correct attempt was significantly reduced at visit 2 [2.17 (±1.53) at visit 1 and 1.82 (±1.11) at visit 2, P = 0.005]. The average number of attempts required for the first correct attempt at visits 1 and 2 for healthy participants was 2.48 (±1.72) and 1.96 (±1.14) (P = 0.017), respectively, and for patients was 1.86 (±1.26) and 1.68 (±1.08) (P = 0.151), respectively [Figure 4].
|Figure 4: Number of attempts required by the participants for the first correct attempt|
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Number and type of errors while using the study device during both the visits
The most frequent errors while using the device included improper or inadequate exhalation prior to inhalation and slow inhalation. The overall number and type of errors (including critical errors) reduced at visit 2 compared to visit 1, with patients already experienced in using inhaler devices making fewer errors than the healthy participants [Figure 5].
Number and type of errors without retraining at visit 2
Without retraining at visit 2, 44% of the participants completed single attempt with no error (critical or non-critical) and 74% of participants completed single attempt with no critical error. Fewer errors were made by patients compared to healthy participants at visit 2 (without retraining), of which the most frequently performed errors were slow inhalation and not holding breath after inhalation.
Assessment of usability of the study device
An average of 93.84% participants found the Revolizer easy to operate, understand, and remember when usability was assessed at both the visits [Figure 6].
Preference and overall participant response to qualitative attributes of the study device
Of the total number of asthma and COPD patients using an inhalation device other than the study device, 78% preferred the Revolizer over their current device.
Additionally, at both the visits, an average of 89.67% participants responded positively in terms of various qualitative attributes such as shape, color, portability, and likeability, and the comfort while operating and handling the device [Table 2].
|Table 2: Participant responses towards qualitative attributes of the Revolizer®|
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Confidence and satisfaction of the participants with the study device
At both the visits, the confidence and satisfaction was assessed with Revolizer [Figure 7] and [Figure 8]. Overall, the participants felt confident and satisfied using the device. They found it easy to use and reported preference for the device.
The Revolizer scored high on usability, response toward qualitative attributes, confidence, and satisfaction of patients at both the visits [Table 3].
During the study period, no adverse events were reported in any patient.
| Discussion|| |
Chronic respiratory diseases such as asthma and COPD have an increasing prevalence worldwide.  Inhalation therapy is the most recommended and accepted form of treating these chronic respiratory diseases.  Recent years have seen an exponential increase in the types of inhaler devices both in India and the world over. However, not all inhalers are patient-friendly and easy to use, with each having their own advantages and disadvantages.
DPIs are the widely prescribed inhalation devices globally.  Revolizer, a novel DPI, is widely marketed in India and our study demonstrates that it scores high on the ease of use, confidence, satisfaction, and preference in patients with asthma and COPD, as well as in healthy participants with no previous experience of using inhalation devices. Similar studies have assessed the handling, preference, and satisfaction with different DPIs in asthma and COPD. ,, This was the first study to assess all the parameters which need to be taken into account while selecting an inhaler device for the patient, such as ease of use, preference, confidence, and satisfaction in patients as well as in healthy participants.
It is further important to analyze whether the device prescribed is easy for the patient to remember and use.  The average time taken by the participants in our study to execute three consecutive correct attempts in using the Revolizer was less than 4 min. The participants in our study were able to correctly use the Revolizer for the first time in less than three attempts at visit 1 and required a maximum of two attempts at visit 2, suggesting that the Revolizer has an inhalation technique which is easy to remember. Remembering the inhaler technique is an important aspect as it can significantly impact the adherence to therapy and can possibly affect disease control. , More than 90% of the participants in our study found the Revolizer technique easy to understand and operate at both the visits, which could probably mean that the Revolizer has a potential to become a device of choice for patients having cognitive or physical impairment, though this would need confirmation in clinical studies.
The inhalation technique varies with each type of DPI, and like any other inhaler device, optimum drug delivery depends on the correct inhalation technique. Errors made by the patients while using an inhaler device can lead to reduced drug delivery adversely impacting the disease control.  The most common errors observed in our study while using Revolizer were inadequate exhalation prior to inhalation and slow inhalation, which are not device dependent but patient dependent and can be overcome by proper instruction and training.  Before retraining at visit 2, the most common errors observed were slow inhalation and not holding the breath after taking the inhalation dose, which were identified as critical errors, and around 74% participants were able to complete a single attempt without any critical error. The patients with asthma and COPD made fewer errors while using the Revolizer compared to the healthy participants throughout the study. The reason for this difference could be that the patients were already using some device prior to the study. Healthy volunteers, on the other hand, probably had no experience with the inhalation therapy at all. The number of errors and critical errors decreased from visit 1 to visit 2 in both patients and healthy volunteers. Our results indicate that with proper instruction and training, correct inhalation technique can be achieved.
In addition to ensuring correct inhalation technique, it is equally important to take the patient preference into account for an inhalation device and this approach is also recommended by the Global Initiative of Asthma Management (GINA).  Patients' attitudes and preference vary from one device to another, even within the DPI category, as seen in previous studies.  In our study, 78% patients preferred the Revolizer over their previous inhaler device that included the pMDI with or without a spacer. The major reasons for such a preference were that the device was easy to remember, use, operate, carry, and clean. More than 75% participants found the Revolizer favorable in terms of shape, color, handling, comfort, portability, and inhalation technique. Patient preference for an inhalation device has the potential to improve satisfaction with the device as well as therapy. 
We not only assessed satisfaction but also confidence with the Revolizer because if participants including the device-naïve were confident of using the prescribed device, they would also be confident of the prescribed therapy, eventually leading to better adherence. To our knowledge, the present study is the only one to have assessed the confidence of the participants about using an inhaler device. There is definitely a need to develop more validated instruments that can assess the patient confidence along with the ease of use, preference, and satisfaction with an inhaler device.
Generally, such device handling studies are of short duration as single- or two-visit studies to ascertain the usability, preference, confidence, and satisfaction with a particular device. , The parameters such as usability, preference, confidence, and satisfaction for an inhaler device should ideally be assessed in a larger and heterogeneous patient population including non-English speaking patients, preferably with a comparator device. These have not been done in this study, which is a study limitation. We are in the process of developing questionnaires on the currently assessed parameters to suit the linguistic diversity for capturing more data from a larger population.
We did not measure the breathing pattern such as rapid and deep inhalation objectively, which could be one of the limitations of our study. The lesser number of COPD patients and short study duration were the other limitations of our study. As errors generally develop over time, it would be worthwhile to perform a study analyzing the number and type of errors with a significant time gap between training and retraining visits. It would also be interesting to repeat a similar study in this population which consists mainly of elderly individuals.
In conclusion, we confirm that the Revolizer is an easy-to-use and a preferred device. It scores high on the satisfaction and confidence in patients and individuals who have never used an inhaler device. Revolizer is a patient-friendly, portable, and comfortable device which is easy to operate and handle. It has the potential to become the device of choice for both patients and physicians alike.
| Acknowledgements|| |
The authors acknowledge the contribution of Late Dr. Pramod Niphadkar as one of the investigators of the study. The authors would like to thank Dr. Sonali Jadhav and Ms. Pallavi Londhe (Cipla Limited) who helped in conducting the study. The writing assistance was provided by Ms. Shweta Joshi and Ms. Khushboo Thakkar (Cipla Limited) in accordance with the CONSORT statement.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
[Table 1], [Table 2], [Table 3]