The characteristics of the study patients are given in Table 2. According to the Global Initiative for Asthma 2015 classification , most patients had mild chronic asthma (32.6%) or moderate persistent asthma (59.8%). More than half of the patients had been treated for asthma for more than 5 years. Before the initiation of therapy with Bufomix Easyhaler®, 54.6% of them were using an ICS and 33.4% were using a LABA with an ICS separately.
In all patients, therapy included Bufomix Easyhaler®, usually used twice daily (93.8%) (Table 2) for at least 2 weeks. Some of the patients continued the therapy for 12 weeks. In addition, 13.9% were advised to continue using another ICS or 0.9% oral corticosteroid at the time of the first control visit after prescription of Bufomix Easyhaler®. Short-acting β2-agonists were used by 43.3% of patients. Concomitant diseases and their medication were reported in 1058 patients (48.1%).
Patients prescribed the higher Bufomix Easyhaler® doses were significantly older, had more concomitant medication, a longer history of asthma, and its more severe clinical presentation (greater prevalence of moderate and severe persistent disease), and were more frequently receiving a LABA with an ICS separately before starting combination therapy (Table 2).
Efficacy Data for Bufomix Easyhaler®
The mean period of exposure to Bufomix Easyhaler® covered by this analysis of efficacy was 142 ± 27 days, from the first visit to the third visit. There was a small insignificant shift in the number of patients from the use of 320/9 µg per inhalation strength toward the use of 160/4.5 µg per inhalation strength during the observation (Table 3). The drop-out of patients from the study groups could impact this observation.
At the first visit, 46.6% of patients had well-controlled or total control of asthma (ACT score 20–25 points) (Table 3). The percentage of patients with well-controlled or total control of asthma increased to 90.8% at the third visit (p < 0.001). The increase was observed for patients treated with 320/9 µg per inhalation strength (from 41.1% to 87.7%; p < 0.001) and for patients treated with 160/4.5 µg per inhalation strength (from 55.0% to 95.5%; p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% at the first visit to 1.2% at the third visit (p < 0.001); see Fig. 1.
The mean ACT score increased by 4.3 points in the whole group, and by 4.5 and 4.2 points in the subgroups receiving higher and lower drug doses, respectively (Table 4).
All patients discontinued therapy with oral steroids during the study period.
The adherence to the use of Bufomix Easyhaler® increased from 88.0% at the first visit to 95.3% at the third visit (Table 3).
Patient Satisfaction with the Use of Bufomix Easyhaler®
Patient satisfaction with the use of the inhaler increased with the duration of use. The percentage of patients who rated the learning to use, using, and handling the inhaler in everyday life as “not so easy,” “not easy,” or “hard” was about 10% at the first visit. The number of patients reporting problems in their use decreased throughout the study, reaching only 3% of the population at the end of study (Table 4). The overall assessment of the inhaler (six-point scale) and assessment of the complexity of the instructions for use are shown in Table 5. Only a few patients assessed the inhaler as unsatisfactory or the inhaler instruction as “not easy” or “difficult” (Fig. 2).
Therapy Discontinuation and Adverse Drug Reactions
Therapy was discontinued in 35 patients (1.6% of the study population), including three patients with reported adverse events (xerostomia, cough, hoarseness after application), three patients in whom Bufomix Easyhaler® was considered ineffective, 12 patients who obtained alleviation of their asthma with time, nine patients in whom the therapy was modified by another physician, three patients for economic reasons, and single individuals because of difficulties in drug application and because of a pregnancy. In three patients the cause of discontinuation was not reported.
The single adverse drug reaction reported by a physician (a cough after application) was probably related to the use of Bufomix Easyhaler®.