Phase 1: Qualitative Interviews
In total, 50 participants completed the qualitative interviews [asthma, n = 25; COPD, n = 25 (COPD population includes one participant with ACO)]. The mean [standard deviation (SD)] age of participants with asthma or COPD was 52.6 (14.4) and 63.1 (9.8) years, respectively. Participants’ mean (SD) disease durations were 20.84 (15.85) years for asthma and 10.42 (6.78) years for COPD; 24% of participants with asthma and 48% with COPD were current smokers (Table 1).
The mean (SD) CAT score for participants with COPD was 22.40 (9.50), indicating a high impact of disease. The mean (SD) ACT score for participants with asthma was 19.72 (4.61), with 15 patients (60%) having ACT scores > 19.
Participants had been prescribed FF/VI for mean (SD) of 0.99 (0.45) years. Ventolin/salbutamol was the next most commonly taken medication. Table S1 contains a full list of current and previous medications.
Participants’ Usage of FF/VI
All but one participant took FF/VI once daily (Table 2). One participant with asthma took FF/VI twice daily on the basis of a recommendation from their doctor, but reported that once-daily dosing would be preferable. Most considered FF/VI easy to use (asthma, n = 25; COPD, n = 23) and felt that FF/VI could be integrated into their daily routine without disruption (asthma, n = 24; COPD, n = 25). Many participants (asthma, n = 19; COPD, n = 15) indicated that they preferred taking a once-daily maintenance medication rather than a more frequent dosage.
Nine participants (asthma, n = 5; COPD, n = 4) considered that a physical aspect of FF/VI affected their frequency of use (Table 2), with the most frequently reported response being that the medication left a powdery taste in the mouth (asthma, n = 1; COPD, n = 3).
Three participants with asthma and five with COPD reported feeling the effects of FF/VI immediately; however, 12 participants with asthma and four participants with COPD could not feel the medication taking effect (Table 2).
Participant Perceptions of FF/VI: Symptoms and Disease Control
The majority of participants with asthma (n = 21) considered that their condition was currently well managed and controlled, whereas only 13 participants with COPD considered their current condition and symptoms to be manageable (Table 2).
A high proportion of participants (asthma, n = 18; COPD, n = 16) reported that their symptoms were controlled after taking one dose of FF/VI. Of those whose asthma symptoms were not fully controlled, all seven indicated that they felt an improvement in symptom control since beginning treatment with FF/VI. Of the seven patients with COPD that were asked, five felt their symptoms were controlled better after a dose of FF/VI compared with previous treatments (Table 2). When asked about their symptoms since starting on FF/VI, one participant with asthma stated, “I know that I feel better in myself, I know that I’m breathing easier and I know it’s only since I started taking [FF/VI] so I can only assume it’s the [FF/VI] that’s done this”. Another participant noted, “I do still have episodes of feeling chesty, what I class as chesty and I still cough a lot which is another symptom of asthma so there are things that still go on as part of the asthma, they never 100% go away”.
Eleven participants with asthma and 16 with COPD felt that their symptoms were controlled all day, while three participants with asthma felt their symptoms were possibly controlled for longer than 24 h (Table 2). Seventeen participants with asthma and 11 with COPD considered that the length of symptom control was “better” with FF/VI compared with previous medications, although five participants with COPD considered that symptom control with FF/VI was the same. Some COPD participants were not sure whether their symptoms were controlled after a dose of FF/VI (n = 2), felt their symptoms were sometimes controlled (n = 1), reported that FF/VI treatment “doesn’t really make a lot of difference” to symptom control (n = 1), and felt unable to compare FF/VI with their previous treatment because of the number of other medications they were taking (n = 2).
Medications mentioned in comparison to FF/VI via the ELLIPTA inhaler included Becotide, Seretide, Symbicort, Clenil, beclomethasone, Qvar, and salbutamol by asthma patients, and Seretide, Genuair, Spiriva, and Fostair by COPD patients.
Effects of FF/VI on Participants’ QoL
The effect of FF/VI on participants’ daily activities varied across the two conditions, ranging from unchanged (n = 2) to improved (n = 2; because of reduced reliance on reliever inhaler) in the asthma group and worsening (n = 2; because of COPD deterioration) to improved (n = 3) in the COPD group. The majority of participants questioned about physical activities reported improvements (asthma, n = 13; COPD, n = 15), whereas six asthma and seven COPD participants reported no change since starting treatment with FF/VI. Specific improvements included positive impact on walking, exercise, climbing the stairs, and the ability to take up new physical activities; generally, participants with asthma were able to do more and/or for longer, while participants with COPD found physical activities easier than before starting treatment with FF/VI. One participant with COPD stated, “if I take [FF/VI] in the morning […] I can do my normal activities for the day, that I wouldn’t be able to do normally anyway with my condition”. Nine participants with asthma and one participant with COPD felt that FF/VI had a positive impact on their social life; those with asthma felt more confident when socializing as they were either less concerned about having an asthma attack or less tired and breathless, and the participant with COPD reported that FF/VI made them feel safe and secure. Seven asthma and 10 COPD participants, respectively, reported no change in their social life since starting treatment with FF/VI.
More participants with asthma than COPD considered that their sleep quality had improved with FF/VI treatment (asthma, n = 13; COPD, n = 4), largely owing to a reduction in the number of nighttime awakenings due to symptoms. Nine participants with asthma and 12 with COPD reported no change in their sleep quality, two of whom reported still waking during the night. One participant with COPD considered that their sleep quality had worsened since commencing FF/VI treatment.
The majority of participants with asthma (n = 18) and COPD (n = 15) did not report any side effects associated with treatment with FF/VI. Of the side effects that were reported, the most frequent were dry mouth (asthma, n = 4; COPD, n = 7) and thrush (asthma, n = 3; COPD, n = 2), none of which were reported as serious adverse events. When questioned further, seven participants with asthma and five with COPD indicated that avoiding side effects was important to them.
The majority of participants in both groups (asthma, n = 24; COPD, n = 23) felt confident with FF/VI treatment and, furthermore, 17 participants with asthma reported feeling “very confident” in their treatment. The most frequent reasons for confidence in FF/VI were the control of symptoms (asthma, n = 12; COPD, n = 14), reduced usage of their reliever medication (asthma, n = 3), increase in personal confidence (asthma, n = 3), and ease of use/convenience (COPD, n = 3). Two participants with COPD reported not feeling confident in FF/VI treatment because they did not feel the treatment had made a difference to their condition (n = 1) or as a result of medication side effects (n = 1). In general, however, participants reported a positive experience with FF/VI, with 20 participants with asthma and 15 with COPD considering FF/VI to be favorable compared with previous treatments. Further results of the impact of FF/VI in phase 1 are included in Table 2 and the online supplement.
Phase 2: Quantitative Survey
Two hundred participants completed the patient survey [asthma, n = 100; COPD, n = 100 (COPD population includes four participants with ACO)], of whom 197 (98.5%) completed the survey either online (n = 152) or via a tablet at their clinical site (n = 45). Two participants (1.5%) completed a paper version of the survey. Data from one participant with COPD (0.5%) who completed the paper survey was excluded from analysis because they received assistance from a family member in completing the survey; all other participants read and responded to either the online or paper survey themselves. Forty-seven participants (23.6%) completed the survey with assistance from the research team [asthma, n = 15 (15.0%); COPD n = 32 (32.3%)]; these individuals were generally older than those who self-completed the survey (mean age 69.5 versus 61.7 years, respectively). In total, data from 199 participants were analyzed (asthma, n = 100; COPD, n = 99).
The demographics and clinical characteristics of participants are shown in Table 1. The mean (SD) age of participants with asthma or COPD was 57.2 (17.0) and 70.0 (9.2) years, respectively. Participants with asthma had a mean (SD) disease duration of 23.9 (19.4) years, and those with COPD had a duration of 8.1 (8.3) years; 14.0% of participants with asthma and 23.2% with COPD were current smokers. The mean (SD) ACT score for participants with asthma was 19.0 (4.6), and 56.0% had an ACT score ≥ 20 (controlled). The mean (SD) CAT score for participants with COPD was 17.7 (9.5), and 22.2% had a CAT score < 10 (low impact). At the time of the survey, rescue medication was being taken by a higher number of individuals with COPD (92.9%) compared with asthma (72.0%).
Participants’ Usage of FF/VI
Participants with asthma had been taking FF/VI for a mean (SD) of 1.4 (1.0) years and those with COPD for 1.9 (1.9) years (Table 3). The majority of participants in both groups reported taking FF/VI once daily (asthma, 86.0%; COPD, 82.8%) and as part of their morning routine (asthma, 87.0%; COPD, 93.9%). Almost all participants reported that FF/VI was easy or very easy to use (asthma, 97.0%; COPD, 91.7%) and fit into their daily routine (asthma, 99.0%; COPD, 96.0%), and the majority found it convenient or very convenient to take as instructed (asthma, 95.0%; COPD, 92.9%).
Participants’ Satisfaction with FF/VI
Most participants reported being satisfied or very satisfied with the frequency at which FF/VI was taken (asthma, 92.0%; COPD, 80.8%) and its ability to control their symptoms (asthma, 91.0%; COPD, 74.7%). The majority of participants were satisfied or very satisfied with the speed of onset (asthma, 89.0%; COPD, 74.7%) and duration of FF/VI’s effect (asthma, 90.0%; COPD, 75.8%), and were confident or very confident that it would relieve their symptoms all day (asthma, 84.0%; COPD, 70.7%). In almost all cases, the percentage of participants reporting satisfaction with the attributes of FF/VI was higher among participants with asthma than with COPD; some of these differences were statistically significant (Table 3).
Over three quarters of participants with asthma were satisfied or very satisfied with their ability to sleep through the night while taking FF/VI (78.0%) and with the level of impact FF/VI had on their ability to do physical or social activities (77.0% and 87.0%, respectively). For patients with COPD, 56.6% were satisfied or very satisfied with their ability to sleep through the night while taking FF/VI, with similar levels of satisfaction observed regarding the level of impact that FF/VI had on their ability to do physical or social activities (54.6% and 59.6%, respectively) (Table 3).
The majority of participants in both disease groups reported being satisfied or very satisfied with their overall experience of using FF/VI (asthma, 90.0%; COPD, 84.8%) (Table 3).
Most patents (asthma, 93.0%; COPD, 92.9%) reported that they would like to continue using FF/VI. Sample free-text responses to questions on participants’ experience of FF/VI are included in the supplementary materials.
Participants’ Satisfaction with FF/VI Compared with Their Most Recent Inhaled Medication
Fifty-four participants with asthma (54.0%) reported recent use of another maintenance inhaler medication for a mean (SD) duration of 5.8 (5.0) years. Sixty-three participants with COPD (63.6%) reported recent use of another maintenance inhaler medication for a mean (SD) duration of 4.2 (4.6) years. The most recent medications taken, most of which participants reported taking twice daily (asthma, 68.5%; COPD, 25.4%), are provided in Table 4.
Compared with their previous maintenance medication, significantly more participants with asthma were satisfied with the frequency of use of FF/VI (P = 0.001) and reported that FF/VI fitted more easily into their daily routine (P = 0.001), was more convenient to take as instructed (P = 0.009), and easier to use (P = 0.003), and that they forgot to take FF/VI less often (P = 0.003). Conversely, participants with COPD did not report significant advantages for FF/VI over their most recent medication; however, a numeric trend towards an advantage was observed (Table 5).
Participants with asthma were also significantly more satisfied with the efficacy of FF/VI compared with their recent maintenance medication, including time to onset of effect, symptom control, and post-dose duration of effect, and they felt confident that their symptoms would be relieved all day (all P < 0.001). Participants with asthma were also significantly more satisfied with the QoL impacts of FF/VI compared with their recent maintenance medication in terms of the impacts on their ability to perform physical and social activities, and their ability to sleep through the night (all P < 0.001) (Table 5).
Compared with their previous medication, participants with COPD were significantly more satisfied with the speed of onset of effect of FF/VI (P = 0.008), its impact on sleep quality (P = 0.031), the protection it conferred against triggers of exacerbations/flare-ups (P = 0.003), and how anxious/depressed they felt about their condition (P = 0.035). There was, however, no significant difference in level of satisfaction with the ability of both medications to control symptoms, duration of symptom control, or level of confidence that symptoms would be relieved (all P ≥ 0.055) (Table 5).
A significantly greater percentage of participants with asthma were satisfied or very satisfied with their overall experience of FF/VI, compared with their recent previous maintenance inhaler (87.0% versus 46.3%, respectively; P < 0.001) (Table 5). For those with COPD, there was no significant difference in participant satisfaction between FF/VI and participants’ previous medication in terms of QoL impacts, including ability to sleep through the night (P ≥ 0.151) and impact on ability to do physical and social activities (P = 0.143 and P ≥ 0.151, respectively). Consequently, there was no significant difference in the number of COPD participants who reported being satisfied or very satisfied with their overall experience of FF/VI compared with their recent previous maintenance inhaler (84.1% versus 76.2%; P = 0.055).