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

被引：3

作者：

Juvekar, Meenesh R. ^{[1
]}

Vaidya, Gauri Kapre ^{[2
]}

Majumder, Aniruddha ^{[3
]}

Pendharkar, Amod D. ^{[4
]}

Irudhayarajan, Anthony ^{[5
]}

Kundu, Avijit ^{[6
]}

Ramesh, D. ^{[7
]}

Kumar, J. Dheeraj ^{[8
]}

Jagannatha, B. ^{[9
]}

Mathew, Joseph ^{[10
]}

Nikam, Mahesh P. ^{[11
]}

Mehta, Madhuri ^{[12
]}

Chawla, Neeraj ^{[13
]}

Hajare, Priti ^{[14
]}

Gowda, P. G. Chandre ^{[15
]}

Murthy, P. V. L. N. ^{[16
]}

Mathew, Suma Moni ^{[17
]}

Damle, Makarand V. ^{[18
]}

Kant, Chandra ^{[19
]}

Nair, Arun B. ^{[20
]}

Jaiswal, Ashok ^{[21
]}

Mehta, Ravi T. ^{[21
]}

机构：

[1] Juvekar Nursing Home, ENT Dept, Mumbai, Maharashtra, India

[2] Neeti Clin, Nagpur, Maharashtra, India

[3] Special ENT Clin, Kolkata, West Bengal, India

[4] Shri Ram Nursing Home, ENT Dept, Satara, Maharashtra, India

[5] Dr Anthonys ENT Ctr, Chennai, Tamil Nadu, India

[6] Suraksha, Barakpur, West Bengal, India

[7] Apollo Family Clin, ENT Dept, Chennai, Tamil Nadu, India

[8] Virinchi Hosp, ENT Dept, Hyderabad, Telangana, India

[9] KIMS & RC, Dept Plast Surg, Bangalore, Karnataka, India

[10] Lisie Hosp, ENT Dept, Cochin, Kerala, India

[11] Shreepad Hosp, ENT Dept, Nasik, Maharashtra, India

[12] N C Jindal Inst Med Care & Res, ENT Dept, Hisar, Haryana, India

[13] Delhi Hosp, ENT Dept, Delhi, India

[14] KLEs Dr Prabhakar Kore Hosp, Med Res Ctr, ENT Dept, Belagavi, Karnataka, India

[15] Sankalpa ENT Care Ctr, Bangalore, Karnataka, India

[16] Star Hosp, ENT Dept, Hyderabad, Telangana, India

[17] Christian Mission Hosp, ENT Dept, Madurai, Tamil Nadu, India

[18] Metro ENT Hosp, Mumbai, Maharashtra, India

[19] Dr Chandrakant Clin, Ranchi, Jharkhand, India

[20] Gitanjali Eye & ENT Hosp, Thiruvananthapuram, Kerala, India

[21] Zydus Healthcare Ltd, Med & Regulatory Affairs, Walia Business Pk, Goregaon, Mumbai 400063, Maharashtra, India

来源：

CLINICAL DRUG INVESTIGATION | 2024年 / 44卷 / 02期

关键词：

MANAGEMENT; IMPACT;

D O I：

10.1007/s40261-023-01338-8

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：123 / 130

页数：8