The assessment of effectiveness, tolerance, and patient satisfaction with the use of a new fixed-dose combination product, containing salmeterol and fluticasone propionate, Salflumix Easyhaler® in the treatment of asthma in the daily clinical practice.

BACKGROUND: The effectiveness of a fix-dose salmeterol/fluticasone combination therapy in asthma was previously shown for the original product. The study aim was to evaluate the clinical effectiveness and safety of a second entry DPI - dry powder inhaler (Salflumix Easyhaler) in patients with asthma in everyday clinical practice. PATIENTS AND METHODS: This multicenter Investigator-Initiated Study that enrolled 2,037 adult outpatients with asthma treated with Salflumix Easyhaler, was conducted by 220 pulmonologists across Poland. Asthma control was assessed during 3 visits with 6 ± 2 weeks intervals based on the Asthma Control Test (ACT). In addition, patient Satisfaction with Asthma Treatment Questionnaire (SATQ) and adherence and adverse events (AEs) were monitored. RESULTS: During the observation (86 ± 30 days) the percentage of patients with controlled asthma (ACT 20-25 pts) increased from 35.5% at the first visit to 86.5% at the third visit (p < 0.001). In the subgroup analysis, there were more patients not obtaining asthma control among patients that switched from the treatment with other devices than in naive ones. Global SATQ scores increased from 5.8 ± 0.7 to 6.2 ± 0.6 during the observation. Patients' satisfaction with the use of the Salflumix Easyhaler was high. Adherence exceeded 95%. Eight AEs were reported. CONCLUSIONS: Salflumix Easyhaler is highly effective and well-tolerated by naïve patients with asthma and those switching from another device. In general, patients show good compliance with medical product and are satisfied with the use of this new device, and not reporting difficulties and errors related to its' use. Their physicians' overall perception of Salflumix Easyhaler use is very positive.

Usage and usability of one dry powder inhaler compared to other inhalers at therapy start: an open, non-interventional observational study in Poland and Germany.

INTRODUCTION: Inhalation is the preferred route of drug administration for patients with asthma or COPD. It is generally predicted that there is a high error rate in inhaler usage, especially at the therapy start. The primary objective of this study was the validation of a questionnaire that can be used for assessing a successful inhalation technique, patient satisfaction as well as the compliance in daily practice.The secondary objective was to examine the "real-life" usage of one inhalation device in comparison with other devices at the start of the therapy. MATERIAL AND METHODS: This open, multi centre and non-interventional study was designed to examine usage and usability of dry powder inhaler Easyhaler® (EH) (Orion Pharma, Finland) and other inhalers assessed by the physicians as well as by the patients. Inclusion criteria for patients were a physician-diagnosis of COPD or asthma or children with asthmatic disease, therapy start with an inhalation device and no or only few experiences with inhaler usage (inhaler usage for not more than 3 months). Each physician enrolled an equal number of patients in each group. RESULTS: 263 adult/adolescent patients with asthma and 115 with COPD as well as 164 children with asthmatic disease were enrolled. 49.4% of the adult/adolescent patients with asthma used an EH and 50.6% other inhalers. In the case of COPD, 47.8% were treated with an EH and 52.2% used other inhalation devices. Finally, 50.6% of the children with asthmatic disease used an EH and 49.4% were treated with other inhalers. Inhaler usage, patient satisfaction, compliance and patients assessments of usability were better when the patients used an EH. Inconvenient features were mainly documented for other inhalers. The analysis of Cronbachs alpha clearly showed the consistency of the received data from all patients. In addition, there was a large association between the assessment of the inhaler usage and the general assessment of the used inhaler in all patient groups. CONCLUSION: The results of this study show that investigators found EH easy to teach, the patients found it easy to use and their satisfaction with the device was high in comparison to other inhalation devices. Thus EH can be matched to many patients already at the therapy start. In addition, the high consistency of the received data and large association of the assessment of the inhaler usage and the general assessment of the inhaler indicate that the used questionnaires were appropriate tools to examine usage and usability of inhaler devices in adult patients and children.

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice.

INTRODUCTION: The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler®) in the daily clinical practice of asthma therapy. METHODS: This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler® for at least 14 days before enrolment. Asthma control was assessed during three subsequent visits with 8-12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with Bufomix Easyhaler® was scored, and adverse drug reactions were recorded. RESULTS: The percentage of patients with well-controlled asthma or total control of asthma (ACT score 20-25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry powder inhaler increased with the duration of its use. Only one adverse drug reaction was reported. CONCLUSION: The results obtained confirm the effectiveness of Bufomix Easyhaler® in the treatment of asthma in outpatient adults in daily clinical practice. FUNDING: Orion Corporation.