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

Abstract

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.

Keywords:

• fix-dose salmeterol/fluticasone combination therapy
• asthma
• real-life data
• patients satisfaction

Acknowledgments

We would like to thank all participating physicians for the data collection and the team of EUROMEDIC Medical Centre for the study management and statistical analysis.

Author contributions

The study was initiated and designed by Zbigniew Doniec, Magdalena Olszanecka-Glinianowicz, and Agnieszka Almgren-Rachtan. EUROMEDIC Medical Center represented by Agnieszka Almgren Rachtan was the study organizer responsible for data collecting, management, and providing the study. Piotr Hantulik supervised the safety management plan and safety data. Data and statistical analyses were supervised by Jerzy Chudek. The manuscript was drafted till the final version by Jerzy Chudek. All authors critically revised and gave final approval to the manuscript.

Compliance with ethics guidelines

Monitoring of the authorized medical product Salflumix Easyhaler^® efficacy and in daily clinical practice (real life) was in line with the requirements of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ I. 311 of 28.11.2001, p. 67 as amended), Directive 2001/83/EC and Act of 6 September 2001 Pharmaceutical Law (Journal of Laws of 2001, No. 126, item 1381, as amended), ART 1(15) and Act of 12 May 2011 on the reimbursement of drugs and foodstuffs for particular nutritional uses and medical devices (Journal of Laws of 2011, No. 122, item 696, as amended), ART 107 m(1) and Act of 27 August 2004 on health care services financed from public funds (Journal of Laws of 2004, No. 210, item 2135, as amended), Regulation EC No 726/2004 (REG) Art 28 b and Act of 5 December 1996 on the professions of doctor and dentist (Journal of Laws of 1997, No. 28, item 152, as amended), and the Medical Code of Ethics of January 2, 2004.

Figure 1. Asthma control obtained with salmeterol/fluticasone propionate fix-dose combination therapy (Salflumix Easyhaler^®) during 3 visits n the whole group (upper panel) and naïve (middle panel) and switched to Salflumix Easyhaler^® (lower panel) subgroups, separately (p < 0.001; χ2 for trend for all panels).

Declaration of interest

Zbigniew Doniec, Magdalena Olszanecka-Glinianowicz and Agnieszka Almgren Rachtan received payment from Euromedic as the medical consultants responsible for the study. Agnieszka Almgren-Rachtan is employed by EUROMEDIC (Head of the Medical Center). Piotr Hantulik is employed by Orion Pharma Poland Co.ltd. (Eastern Europe Medical Manager). Jerzy Chudek received an honorarium for data analysis and manuscript preparation.

Data availability

The datasets generated during and/or analyzed during the current study are available from the EUROMEDIC Medical Center on reasonable request.

Additional information

Funding

The study was funded by Euromedic Medical Center in 25% and supported by a research grant by Orion Pharma in 75%. Orion Pharma was not involved in the conduct of the study and analyses.