Abstract
Background
Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.
Objective
This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.
Methods
A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.
Results
VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.
Conclusion
MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.
Statement of Ethics
Subjects (or their parents or guardians) have given their written informed consent. This investigation represented a NIS as defined by European regulations [European Union Directive 2001/20/EC, ICH E2E, European Medicines Agency Guideline on good pharmacovigilance practices (GVP)], ie, the rules imposed for this observational plan did not interfere with the physician’s common therapy. The study was carried out in accordance with the national laws and guidelines current at that time: LVFS 2003:6, LIF policy 2010:1. The study documents were submitted to the Ethics Committee (EC) in Stockholm for review. This EC provided a positive opinion during the session on 22 Oct 2014.
Acknowledgment
The authors acknowledge Arghya Bhattacharya and Aswin Kumar A, for medical writing support (Viatris). Data included in this manuscript have been previously presented at the European Academy of Allergy and Clinical Immunology Congress (P0653, P0655, and P1177) held June 17‒21, 2017, in Helsinki, Finland.
Disclosure
P.S. reports being on the advisory board for Meda. J.S. has nothing to disclose. D.T.N. and H.C.K. are employees of Meda Pharma GmbH & Co. KG (A Mylan Company, now Viatris). The authors report no other conflicts of interest in this work.