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

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 congesti...

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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
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container_start_page 123
container_title Clinical drug investigation
container_volume 44
creator 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.
description 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  
doi_str_mv 10.1007/s40261-023-01338-8
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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.</creator><creatorcontrib>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.</creatorcontrib><description>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  &lt; 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 ( p  &lt; 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 ( p &lt;  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.</description><identifier>ISSN: 1173-2563</identifier><identifier>EISSN: 1179-1918</identifier><identifier>DOI: 10.1007/s40261-023-01338-8</identifier><identifier>PMID: 38195833</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Cold remedies ; Hay fever ; Internal Medicine ; Likert scale ; Medicine ; Medicine &amp; Public Health ; Nose ; Observational studies ; Original Research Article ; Patient compliance ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Quality of life ; Rhinitis ; Steroids</subject><ispartof>Clinical drug investigation, 2024-02, Vol.44 (2), p.123-130</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><rights>Copyright Springer Nature B.V. Feb 2024</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-89d22bf3f5c4500fc94759f98109af57c70ea5df78d8a53b18f34e8a3952c9883</cites><orcidid>0000-0001-6745-9391</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38195833$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Juvekar, Meenesh R.</creatorcontrib><creatorcontrib>Vaidya, Gauri Kapre</creatorcontrib><creatorcontrib>Majumder, Aniruddha</creatorcontrib><creatorcontrib>Pendharkar, Amod D.</creatorcontrib><creatorcontrib>Irudhayarajan, Anthony</creatorcontrib><creatorcontrib>Kundu, Avijit</creatorcontrib><creatorcontrib>Ramesh, D.</creatorcontrib><creatorcontrib>Kumar, J. Dheeraj</creatorcontrib><creatorcontrib>Jagannatha, B.</creatorcontrib><creatorcontrib>Mathew, Joseph</creatorcontrib><creatorcontrib>Nikam, Mahesh P.</creatorcontrib><creatorcontrib>Mehta, Madhuri</creatorcontrib><creatorcontrib>Chawla, Neeraj</creatorcontrib><creatorcontrib>Hajare, Priti</creatorcontrib><creatorcontrib>Gowda, P. G. Chandre</creatorcontrib><creatorcontrib>Murthy, P. V. L. N.</creatorcontrib><creatorcontrib>Mathew, Suma Moni</creatorcontrib><creatorcontrib>Damle, Makarand V.</creatorcontrib><creatorcontrib>Kant, Chandra</creatorcontrib><creatorcontrib>Nair, Arun B.</creatorcontrib><creatorcontrib>Jaiswal, Ashok</creatorcontrib><creatorcontrib>Mehta, Ravi T.</creatorcontrib><title>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</title><title>Clinical drug investigation</title><addtitle>Clin Drug Investig</addtitle><addtitle>Clin Drug Investig</addtitle><description>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  &lt; 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 ( p  &lt; 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 ( p &lt;  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. 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Dheeraj</au><au>Jagannatha, B.</au><au>Mathew, Joseph</au><au>Nikam, Mahesh P.</au><au>Mehta, Madhuri</au><au>Chawla, Neeraj</au><au>Hajare, Priti</au><au>Gowda, P. G. Chandre</au><au>Murthy, P. V. L. N.</au><au>Mathew, Suma Moni</au><au>Damle, Makarand V.</au><au>Kant, Chandra</au><au>Nair, Arun B.</au><au>Jaiswal, Ashok</au><au>Mehta, Ravi T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Clinical drug investigation</jtitle><stitle>Clin Drug Investig</stitle><addtitle>Clin Drug Investig</addtitle><date>2024-02-01</date><risdate>2024</risdate><volume>44</volume><issue>2</issue><spage>123</spage><epage>130</epage><pages>123-130</pages><issn>1173-2563</issn><eissn>1179-1918</eissn><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  &lt; 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 ( p  &lt; 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 ( p &lt;  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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>38195833</pmid><doi>10.1007/s40261-023-01338-8</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-6745-9391</orcidid></addata></record>
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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
title 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
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