Journal of Asthma and Allergy (Jun 2022)

Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion

  • Kumar RS,
  • Jain MK,
  • Kushwaha JS,
  • Patil S,
  • Patil V,
  • Ghatak S,
  • Sanmukhani J,
  • Mittal R

Journal volume & issue
Vol. Volume 15
pp. 783 – 792

Abstract

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RS Kumar,1 Manish Kumar Jain,2 Jitendra Singh Kushwaha,3 Santosh Patil,4 Vasanti Patil,5 Soumya Ghatak,6 Jayesh Sanmukhani,7 Ravindra Mittal7 1Department of Pulmonary Medicine, Government Medical College & Government General Hospital, Srikakulam, India; 2Department of Pulmonary Medicine, Maharaja Agrasen Superspeciality Hospital, Jaipur, India; 3Department of Medicine, Prakhar Hospital Pvt. Ltd, Kanpur, India; 4Department of ENT, Jeevan Rekha Hospital, Belgavi, India; 5Department of ENT, Rajarshi Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, India; 6Department of ENT, College of Medicine and Sagore Dutta Hospital, Kolkata, India; 7Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, IndiaCorrespondence: Jayesh Sanmukhani, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Ltd, Ahmedabad, India, Tel +91 76000 12192, Email [email protected]; [email protected]: To compare the efficacy and safety of a fixed dose combination of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray 27.5/50 mcg (FDC) with Fluticasone Furoate Nasal Spray 27.5 mcg (Fluticasone) in the management of allergic rhinitis.Patients and Methods: A prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, comparative clinical study was conducted in patients with allergic rhinitis aged 18 years and above having moderate-to-severe nasal congestion.Results: A total of 250 patients were randomized (1:1) to receive either the FDC or Fluticasone alone in a dose of two sprays in each nostril once daily at night. There was a significantly (P 0.05).Conclusion: The FDC was superior to Fluticasone alone in relieving the nasal congestion and reduction of Total Nasal Symptom Score in allergic rhinitis patients with moderate-to-severe nasal congestion when administered once daily in the evening. Oxymetazoline when used along with the nasal steroid in a once daily dose does not cause rebound congestion and rhinitis medicamentosa even after long-term continuous use of 28 days.Keywords: Fluticasone Furoate, oxymetazoline, nasal spray, allergic rhinitis, nasal congestion

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