Abstract
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 < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported.
Conclusion
The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.
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Data Availability Statement
The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at Insignia Communications Pvt. Ltd., India.
Code Availability
Not applicable.
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Acknowledgements
Insignia Communications Pvt. Ltd. in Mumbai, India, wrote the manuscript and carried out the data analysis. Authors Dr. Meenesh R. Juvekar, Dr. Ashok Jaiswal and Dr. Ravi T. Mehta acknowledge Dr. Reshma Susan Mathew (M.S., ENT) for her scientific assistance in the conduct of the study.
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This study was funded by Zydus Healthcare Limited, including data analysis and manuscript writing.
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Dr. Ravi Tejraj Mehta and Dr. Ashok Jaiswal are employees of Zydus Healthcare Limited, India. Other authors report no conflicts of interest with regard to this study.
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This study was approved by the Ethics Committee, dated: 01/03/2022. The study was registered on Clinical Trials Registry-India, Registration No: CTRI/2022/05/042785 [Registered on: 24/05/2022].
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Juvekar, M.R., Vaidya, G.K., Majumder, A. et al. 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. Clin Drug Investig 44, 123–130 (2024). https://doi.org/10.1007/s40261-023-01338-8
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DOI: https://doi.org/10.1007/s40261-023-01338-8