The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial

<b>Background</b>: Mometasone furoate nasal spray is efficacious in relieving allergic rhinitis symptoms. The objectives of this study were, firstly, to compare the efficacy of Elonide to Nasonex<sup>®</sup> and a placebo and secondly, to investigate the side effects of Eloni...

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Main Authors: Hardip S. Gendeh, Aneeza W. Hamizan, Salina Husain, Azmawati M. Nawi, Farah D. Zahedi, Nur Fadhilah Megat Ismail, N. Ammal M. Farit
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/13/7/1883
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author Hardip S. Gendeh
Aneeza W. Hamizan
Salina Husain
Azmawati M. Nawi
Farah D. Zahedi
Nur Fadhilah Megat Ismail
N. Ammal M. Farit
author_facet Hardip S. Gendeh
Aneeza W. Hamizan
Salina Husain
Azmawati M. Nawi
Farah D. Zahedi
Nur Fadhilah Megat Ismail
N. Ammal M. Farit
author_sort Hardip S. Gendeh
collection DOAJ
description <b>Background</b>: Mometasone furoate nasal spray is efficacious in relieving allergic rhinitis symptoms. The objectives of this study were, firstly, to compare the efficacy of Elonide to Nasonex<sup>®</sup> and a placebo and secondly, to investigate the side effects of Elonide. <b>Method</b>: This was a prospective, single-centered, double blinded, randomized, placebo-controlled, non-inferiority trial. A total of 163 participants from the Otorhinolaryngology Clinic, Hospital Canselor Tuanku Muhriz (HCTM), were randomized into three treatment groups receiving Elonide (n = 56), Nasonex<sup>®</sup> (n = 54), and placebo (n = 53) nasal sprays using an online randomizer (Random.org). Treatment was administered for 4 weeks. The primary outcome measure was the Total Nasal Resistance (TNR), and the secondary outcomes were the Visual Analogue Score (VAS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) score. Side effects were recorded. <b>Results</b>: There were significant improvements for all groups from baseline. The Elonide group had the greatest mean difference for all primary and secondary outcomes compared to Nasonex<sup>®</sup> and the placebo (0.77 ± 2.44 vs. 0.35 ± 1.16, <i>p</i> = 1.00 vs. 0.17 ± 0.82, <i>p</i> = 0.01). Elonide is non-inferior to Nasonex (<i>p</i> = 1.00) and superior to the placebo (<i>p</i> < 0.05). The highest side effects reported were for Nasonex (n = 14, 26%), followed by the placebo (n = 8, 16%) and Elonide (n = 6, 12%); headaches (n = 9, 17%) and sore throat (n = 9, 17%) were the most common. <b>Conclusions</b>: Elonide has similar efficacy to Nasonex<sup>®</sup> when compared to a placebo in the treatment of AR in adults. Elonide is safe and tolerable, with fewer side effects and no adverse side effects.
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spelling doaj.art-127366400f2b42d0a0fd1b49c27be6722024-04-12T13:20:55ZengMDPI AGJournal of Clinical Medicine2077-03832024-03-01137188310.3390/jcm13071883The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded TrialHardip S. Gendeh0Aneeza W. Hamizan1Salina Husain2Azmawati M. Nawi3Farah D. Zahedi4Nur Fadhilah Megat Ismail5N. Ammal M. Farit6Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, MalaysiaDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, MalaysiaDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, MalaysiaAllergic Unit, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Kuala Lumpur 56000, MalaysiaDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, MalaysiaDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, MalaysiaDepartment of Pharmacy, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia<b>Background</b>: Mometasone furoate nasal spray is efficacious in relieving allergic rhinitis symptoms. The objectives of this study were, firstly, to compare the efficacy of Elonide to Nasonex<sup>®</sup> and a placebo and secondly, to investigate the side effects of Elonide. <b>Method</b>: This was a prospective, single-centered, double blinded, randomized, placebo-controlled, non-inferiority trial. A total of 163 participants from the Otorhinolaryngology Clinic, Hospital Canselor Tuanku Muhriz (HCTM), were randomized into three treatment groups receiving Elonide (n = 56), Nasonex<sup>®</sup> (n = 54), and placebo (n = 53) nasal sprays using an online randomizer (Random.org). Treatment was administered for 4 weeks. The primary outcome measure was the Total Nasal Resistance (TNR), and the secondary outcomes were the Visual Analogue Score (VAS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) score. Side effects were recorded. <b>Results</b>: There were significant improvements for all groups from baseline. The Elonide group had the greatest mean difference for all primary and secondary outcomes compared to Nasonex<sup>®</sup> and the placebo (0.77 ± 2.44 vs. 0.35 ± 1.16, <i>p</i> = 1.00 vs. 0.17 ± 0.82, <i>p</i> = 0.01). Elonide is non-inferior to Nasonex (<i>p</i> = 1.00) and superior to the placebo (<i>p</i> < 0.05). The highest side effects reported were for Nasonex (n = 14, 26%), followed by the placebo (n = 8, 16%) and Elonide (n = 6, 12%); headaches (n = 9, 17%) and sore throat (n = 9, 17%) were the most common. <b>Conclusions</b>: Elonide has similar efficacy to Nasonex<sup>®</sup> when compared to a placebo in the treatment of AR in adults. Elonide is safe and tolerable, with fewer side effects and no adverse side effects.https://www.mdpi.com/2077-0383/13/7/1883mometasone furoatenasal sprayNasonexnon-inferiorside effects
spellingShingle Hardip S. Gendeh
Aneeza W. Hamizan
Salina Husain
Azmawati M. Nawi
Farah D. Zahedi
Nur Fadhilah Megat Ismail
N. Ammal M. Farit
The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
Journal of Clinical Medicine
mometasone furoate
nasal spray
Nasonex
non-inferior
side effects
title The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
title_full The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
title_fullStr The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
title_full_unstemmed The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
title_short The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
title_sort efficacy of elonide nasal corticosteroids in managing allergic rhinitis a randomized double blinded trial
topic mometasone furoate
nasal spray
Nasonex
non-inferior
side effects
url https://www.mdpi.com/2077-0383/13/7/1883
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