Comparative clinical assessment of mometasone furoate-azelastine hydrochloride intranasal spray (Ryaltris AZ®) with fluticasone furoate-azelastine hydrochloride intranasal spray in patients with allergic rhinitis in India

Authors

  • Kabikant Samantaray Department of ENT, KIMS Hospital, Bhubaneswar, Odisha, India
  • Rajesh Dhir Department of ENT, Dharam hospital, Chandigarh, Punjab, India
  • Sameer Deshmukh Department of ENT, Deshmukh ENT Hospital, Aurangabad, Maharashtra, India
  • Pankaj Srivastava Department of ENT, Pankaj ENT, Lucknow, Uttar Pradesh, India
  • Sagar Bhimrao Bhagat Department of Global Medical Affairs, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, India
  • Saiprasad Patil Department of Global Medical Affairs, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, India
  • Hanmant Barkate Department of Global Medical Affairs, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/issn.2454-5929.ijohns20232220

Keywords:

Mometasone, Azelastine, Fluticasone furoate, Nasal spray, Allergic rhinitis

Abstract

Background: Allergic rhinitis is a type of IgE-mediated hypersensitivity reaction. ARIA recommends a combination of intranasal corticosteroid and intranasal antihistamine as first-line treatment for allergic rhinitis in moderate to severe AR. The current study aimed to compare the effectiveness and safety of Mometasone furoate-Azelastine hydrochloride Nasal Spray and Fluticasone furoate-Azelastine hydrochloride Nasal Spray for the treatment of allergic rhinitis in India.

Methods: A multicentric, comparative study was carried out across 30 ENT clinics in India. From September to November 2022, medical records were scrutinised for information such as medical history, symptoms, treatment details, clinical results, and adverse events. The mean change in total nasal and non-nasal symptom scores from baseline to the end of treatment was used to assess effectiveness.

Results: 235 received mometasone furoate-azelastine hydrochloride intranasal spray and 221 received Fluticasone furoate-Azelastine hydrochloride (FF-Az) Intranasal Spray. The mean change from the baseline TNSS score at day 14 in the MF-AZ and FF-Az groups was -6.89 (±3.32) and -6.82 (±3.20) respectively, with no significant difference (p=0.81) between the two. Bitterness and nasal irritation was significantly higher in the FF-Az group. There was no hospitalization, SAE, or treatment discontinuation due to AEs among patients in either group.

Conclusions: The study found that intranasal mometasone-azelastine and fluticasone furoate-azelastine sprays were equally effective in relieving nasal and non-nasal symptoms by days 7 and 14, respectively. However, patients in the fluticasone furoate-azelastine group reported more bitter taste and nasal irritation.

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Published

2023-07-27

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Original Research Articles