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New patents of fixed combinations of nasal antihistamines and corticosteroids in allergic rhinitis.

Abstract

During the last few years, fixed combinations of intranasal antihistamines and corticosteroids have been introduced for treatment of allergic rhinitis. The aim of this systematic review was to assess recent patents and clinical evidence for fixed combinations of intranasal antihistamines and intranasal corticosteroids in allergic rhinitis. Data base searches revealed that intranasal combinations of the antihistamine azelastine with the corticosteroids mometasone furoate, ciclesonide and fluticasone propionate, respectively, have been patented. Four randomized, double-blinded, parallel-group, placebo-controlled, multicenter trials sponsored by the manufacturer evaluated the fixed combination of intranasal azelastine 125 µg and fluticasone propionate 50 µg administered as one dose per nostril b.i.d. in patients with moderate-to-severe symptomatic allergic rhinitis ≥ 12 years of age. Three of the studies were published as a meta-analysis which found the fixed combination of azelastine and fluticasone propionate statistically significantly more efficacious in reducing baseline total nasal symptom score by 5.7 as compared to azelastine (4.4; P < 0.001), fluticasone propionate (5.1; P < 0.001) and placebo (3.0; P < 0.001). The findings were supported by secondary assessments of scores of specific nasal and ocular symptoms. Pharmacokinetic studies have revealed no drug-drug interactions but a discrete increase in bioavailability of fluticasone propionate which was considered clinically unimportant. Further efficacy and quality-of-life studies of combination products of nasal antihistamines and corticosteroids are needed, especially, in primary care settings and in children before fixed combination treatment can be considered first line therapy in allergic rhinitis. Fixed combination treatment of azelastine and fluticasone propionate may offer additional benefit to selected populations of adolescents and adults with moderate-to-severe symptoms.

Authors+Show Affiliations

Asthma and Allergy Clinic, Children's Clinic Randers, Dytmærsken 9, 8900 Randers, Denmark. akk.odws@dadlnet.dk

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

23862774

Citation

Wolthers, Ole D.. "New Patents of Fixed Combinations of Nasal Antihistamines and Corticosteroids in Allergic Rhinitis." Recent Patents On Inflammation & Allergy Drug Discovery, vol. 7, no. 3, 2013, pp. 223-8.
Wolthers OD. New patents of fixed combinations of nasal antihistamines and corticosteroids in allergic rhinitis. Recent Pat Inflamm Allergy Drug Discov. 2013;7(3):223-8.
Wolthers, O. D. (2013). New patents of fixed combinations of nasal antihistamines and corticosteroids in allergic rhinitis. Recent Patents On Inflammation & Allergy Drug Discovery, 7(3), 223-8.
Wolthers OD. New Patents of Fixed Combinations of Nasal Antihistamines and Corticosteroids in Allergic Rhinitis. Recent Pat Inflamm Allergy Drug Discov. 2013;7(3):223-8. PubMed PMID: 23862774.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - New patents of fixed combinations of nasal antihistamines and corticosteroids in allergic rhinitis. A1 - Wolthers,Ole D, PY - 2013/06/25/received PY - 2013/07/31/revised PY - 2013/08/01/accepted PY - 2013/7/19/entrez PY - 2013/7/19/pubmed PY - 2014/4/1/medline SP - 223 EP - 8 JF - Recent patents on inflammation & allergy drug discovery JO - Recent Pat Inflamm Allergy Drug Discov VL - 7 IS - 3 N2 - During the last few years, fixed combinations of intranasal antihistamines and corticosteroids have been introduced for treatment of allergic rhinitis. The aim of this systematic review was to assess recent patents and clinical evidence for fixed combinations of intranasal antihistamines and intranasal corticosteroids in allergic rhinitis. Data base searches revealed that intranasal combinations of the antihistamine azelastine with the corticosteroids mometasone furoate, ciclesonide and fluticasone propionate, respectively, have been patented. Four randomized, double-blinded, parallel-group, placebo-controlled, multicenter trials sponsored by the manufacturer evaluated the fixed combination of intranasal azelastine 125 µg and fluticasone propionate 50 µg administered as one dose per nostril b.i.d. in patients with moderate-to-severe symptomatic allergic rhinitis ≥ 12 years of age. Three of the studies were published as a meta-analysis which found the fixed combination of azelastine and fluticasone propionate statistically significantly more efficacious in reducing baseline total nasal symptom score by 5.7 as compared to azelastine (4.4; P < 0.001), fluticasone propionate (5.1; P < 0.001) and placebo (3.0; P < 0.001). The findings were supported by secondary assessments of scores of specific nasal and ocular symptoms. Pharmacokinetic studies have revealed no drug-drug interactions but a discrete increase in bioavailability of fluticasone propionate which was considered clinically unimportant. Further efficacy and quality-of-life studies of combination products of nasal antihistamines and corticosteroids are needed, especially, in primary care settings and in children before fixed combination treatment can be considered first line therapy in allergic rhinitis. Fixed combination treatment of azelastine and fluticasone propionate may offer additional benefit to selected populations of adolescents and adults with moderate-to-severe symptoms. SN - 1872-213X UR - https://www.unboundmedicine.com/medline/citation/23862774/New_patents_of_fixed_combinations_of_nasal_antihistamines_and_corticosteroids_in_allergic_rhinitis_ L2 - http://www.eurekaselect.com/114548/article DB - PRIME DP - Unbound Medicine ER -