A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate–Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis

• Published in: Clinical drug investigation 2024-02, Vol.44 (2), p.123-130
• Main Authors: Juvekar, Meenesh R., Vaidya, Gauri Kapre, Majumder, Aniruddha, Pendharkar, Amod D., Irudhayarajan, Anthony, Kundu, Avijit, Ramesh, D., Kumar, J. Dheeraj, Jagannatha, B., Mathew, Joseph, Nikam, Mahesh P., Mehta, Madhuri, Chawla, Neeraj, Hajare, Priti, Gowda, P. G. Chandre, Murthy, P. V. L. N., Mathew, Suma Moni, Damle, Makarand V., Kant, Chandra, Nair, Arun B., Jaiswal, Ashok, Mehta, Ravi T.
• Format: Article
• Language: English
• Subjects: Cold remedies; Hay fever; Internal Medicine; Likert scale; Medicine; Medicine & Public Health; Nose; Observational studies; Original Research Article; Patient compliance; Patients; Pharmacology/Toxicology; Pharmacotherapy; Quality of life; Rhinitis; Steroids
• ISSN: 1173-2563; 1179-1918
• DOI: 10.1007/s40261-023-01338-8

Background Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3–5 days. Objective The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. Methods The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients ( n  = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. Results Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 ( p