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

Abstract

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 Jayesh_sanmukhani@yahoo.co.in; jayeshsanmukhani@zyduscadila.comObjective: 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< 0.001) greater reduction in night-time Total Nasal Symptom Score with the FDC as compared to Fluticasone at all the time points starting from as early as day 3 and sustained till the end of treatment (Day 28) (Day 3: − 3.1 vs − 2.2; Day 7: − 4.0 vs − 3.4; Day 14: − 5.7 vs − 5.0; Day 28: − 7.0 vs − 6.4). A significantly ...