Results
Participant Demographics
A summary of demographic data for participants with asthma and COPD is provided in Table 1. Participants with COPD were typically older than those with asthma and more likely to suffer from co-morbid conditions, such as arthritis, and to be using multiple medications each day. Participants with asthma reported longer duration of disease since diagnosis, and correspondingly longer and more varied history of inhaler use. Participant-reported severity of disease was on average moderate (5.0–5.6/10) for both asthma and COPD.
Findings From Interviews: Key Attributes
Participants reported high levels of satisfaction with and a very positive experience of using the ELLIPTA DPI. Each of the key attributes of the DPI, as targeted by the specific questions asked, were perceived positively by the majority of participants. The findings of the content analysis of the responses to these questions, together with representative quotations for each relevant emergent theme and cluster, are provided in Table 2. The most frequently encountered themes included simplicity of action, speed and ease of operation, fit of the inhaler to the hand and mouthpiece to the lips, and dose count awareness.
Ease of Use
Patients had been briefed at the start of the clinical study by a member of staff at the clinical study site on how to use the ELLIPTA DPI, often with the aid of a demonstration inhaler. When asked about their use of the instruction leaflet, interview participants reported that they had not needed to refer to instructions or ask follow-up questions after having been shown how to use the inhaler. During the free response segment of the interview (prior to the rating of key attributes), several participants spontaneously reported on the straightforwardness and intuitiveness of the use of the DPI, describing the few steps required ("open and inhale, that's it: not much to it") and the time taken to use the ELLIPTA DPI ("a matter of seconds to use"). These sentiments were reflected by the findings of the content analysis of the underlying reasons provided for rating of the ease of use of the ELLIPTA DPI, and amount of time taken to use the inhaler (Table 2). Participants with experience of other DPI use commented on the similarity of the technique used to operate the ELLIPTA DPI to that of inhalers such as the DISKUS™.
Dose Counter
The dose counter of the ELLIPTA DPI helps to provide the user with confirmation that a dose has been delivered from the DPI after they have opened and closed the cover. Participants reported that the dose counter made it easy to stay on track with their medication, and provided an indication of the need to refill. Participants with poor eyesight also reported that the dose counter was clearly readable, without the need for corrective lenses or magnification. The red indicator (which displays when 9 or fewer doses remain in the DPI) was praised by several participants as providing a visual reminder to renew their medication.
Cover
Most participants, particularly those who had previous experience of using a metered dose inhaler (MDI), expressed a positive opinion of the cover (or 'lid') of the ELLIPTA DPI, which is opened in order to activate a dose and uncover the mouthpiece. This cover remains closed when not in use, protecting the mouthpiece, and is therefore considered to be hygienic. The most frequently encountered content themes in relation to the cover were easy to open and close (several patients commented that they could open it with one hand), and simple to operate, with a raised lip which can be slid up using the thumb. MDI users noted that it is useful that the cover remains attached to the body of the inhaler, as opposed to a separate cover which has to be removed and replaced. Some participants remarked that the cover dragged, or sprang back slightly when pushed open, but it was also noted that the inhaler would not open inadvertently (e.g. during transit), thereby wasting a dose, and that it was possible to partially open the DPI without using a dose. Three participants with asthma and four with COPD did report inadvertently actuating the DPI during the clinical trial by opening and closing the cover when they were not ready to inhale a dose, resulting in the loss of the dose. This was typically due to becoming distracted and accidentally opening the cover when not wishing to inhale a dose. No participant reported more than one error resulting in loss of a dose during the clinical trials.
Inhalation
Delivery of medication from the ELLIPTA DPI is achieved by first opening the cover to actuate the dose, then inhaling the medication from the mouthpiece with a long, steady, deep breath. The mouthpiece of the ELLIPTA DPI was reported to be comfortable and well-shaped and to create a good seal with the lips during use. Several participants commented that the mouthpiece increased their confidence that they were receiving a full dose of the medication relative to other inhalers they were currently using. Inhalation itself was described as easy. A frequently-encountered response theme, particularly among participants with COPD, was that the medication can be drawn out of the DPI with a shallow breath. Many participants described being able to feel the powder while inhaling, which provided confirmation that they had received a dose, although some asthma patients expressed preference for a propelled inhaler. A small minority of participants with experience of using an MDI or HandiHaler™ felt that the mouthpiece of the DPI was too short/small.
Handling and Storage
Most participants reported finding the handling of the ELLIPTA DPI to be comfortable and intuitive. Participants commented positively on the ergonomics of the inhaler, with the DPI's fit to the hand, grip and compact size emerging as frequently cited themes. Most participants used two-handed methods to open and close the cover, either pinching the cover between thumb and forefinger or pulling it down with the thumb. A few patients with larger hands used a one-handed method of opening the DPI. Some participants with COPD and arthritis (seven in total) reported experiencing some difficulties with the opening and closing of the DPI during worsening of arthritis symptoms. However, these participants also reported that the ergonomic design and ridged cover meant that they were able to slide open the ELLIPTA DPI without having to grip the cover. In addition, the ridged side grips were considered by participants to decrease the likelihood of the inhaler slipping from the hand. In terms of storage, participants reported that the ELLIPTA DPI is small enough to be carried in a pocket or purse, and that the flat base aids the storage of the inhaler by enabling it to stand unsupported.
Preference Relative to Other Inhalers
A summary of participants' preference for the ELLIPTA DPI relative to other inhalers is provided in Table 3. The majority of participants with asthma and most participants with COPD preferred the ELLIPTA DPI to the inhaler(s) used to deliver their current medication (as prescribed after the end of the clinical study from which they were recruited).
The outcomes of inductive content analysis performed on the reasons given by patients for their preference are provided for asthma patients (Table 4) and COPD patients (Table 5).
The ELLIPTA DPI was preferred to DISKUS in over three quarters of comparisons made by 42 participants with asthma or COPD. The main drivers of preference were the simplicity and ease of use of the ELLIPTA DPI; its ease of handling; size; portability and storage; the shape of the mouthpiece and seal made with the lips on inhalation; and the size and visibility of the dose counter. The mouthpiece seal and ease of handling were the most prominent response themes among participants with COPD, whereas the simplicity of operation and storage and portability of the inhaler were more frequently cited by asthma patients.
The ELLIPTA DPI was preferred to current MDI by over three quarters of participants with asthma or COPD. The most frequently encountered themes underlying preference for ELLIPTA over MDI included the ease, speed and simplicity of operation (in particular, that there is no need to shake or prime the inhaler before use) and that co-ordination of activation of the DPI with inhalation is not required; the reduced number of inhalations needed; the presence of a readable dose counter; the security and hygiene of the ELLIPTA DPI's cover; and the comfort and fit of the mouthpiece.
Assessing COPD participants who were using the Handihaler at the time of the study, all but one participant preferred the ELLIPTA DPI. The main driver of preference was the simplicity of the mode of action of the ELLIPTA DPI compared with that of the HandiHaler, without the need to open a blister pack and insert a capsule into the device ahead of inhalation; and patients' increased confidence that they received a complete dose of medication based on the contoured mouthpiece and simplicity of the device design and operation.
Performance Scores
Indicative performance scores for the ELLIPTA DPI were recorded on a scale of 1 (worst) to 10 (best) for nine separate attributes of the DPI. The scores obtained using this method are provided to aid the interpretation of participants' perceptions of the inhaler that is supported by the textual context provided, and should be viewed with caution in light of the small sample sizes (42 patients with COPD; 33 patients with asthma) from which they are derived.
Average performance scores in participants with asthma and COPD were >9 for all nine attributes (Figure 1). Average performance scores in subgroups of participants with asthma (Figure 2A–B and Figure 3A–C), following stratification by age, severity, duration of diagnosis, and (COPD only) previous DPI use, were >8 in all but one subgroup-category combination. The only score of <8, for the ease of activation attribute, was recorded in the subset of participants with COPD who did not have previous experience in the use of a DPI.
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Figure 1.
Overall performance scores. COPD = chronic obstructive pulmonary disorder.
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Figure 2.
Asthma performance scores by subgroup defined by: A) asthma severity; B) age. Note: asthma severity scores in A range from 1 (not at all severe) to 10 (extremely severe).
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Figure 3.
COPD performance scores by subgroup defined by: A) COPD severity; B) age; C) prior DPI use. Note: COPD severity scores in A range from 1 (not at all severe) to 10 (extremely severe). COPD = chronic obstructive pulmonary disorder; DPI = dry powder inhaler.