Comparison of the Effects of Azelastine and Fluticasone Nasal Sprays in the Treatment of Allergic Rhinitis

Krishnakumar, Dhanya; Faizal, Bini; Nair, Anju

doi:10.1007/s12070-021-02686-7

Cited by 2 publications

(2 citation statements)

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“…AZE has also been shown to have a faster onset of action compared to mometasone in 450 SAR patients aged 18–65 years when tested in an environmental exposure chamber ( 21 ). A prospective study done on 240 patients with AZE and fluticasone (FLU) nasal sprays in a 1:1 ratio concluded that both intranasal AZE and FLU had comparable efficacy in symptom control in patients with AR ( 22 ). Intranasal corticosteroids are still the first-line therapy for the treatment of AR.…”

Section: Discussionmentioning

confidence: 99%

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A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis

Bousquet,

Klimek,

Kuhl

et al. 2023

Front. Allergy

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BackgroundAzelastine hydrochloride (AZE) is a selective, non-sedating H1 antagonist with anti-inflammatory and mast cell stabilizing properties, which can be used as an alternative to intranasal corticosteroids. The objective of this study was to evaluate the efficacy of the new formulation of 0.15% AZE compared to that of the placebo at a dosage of two sprays per nostril twice daily for 4 weeks in patients with perennial allergic rhinitis (PAR).Materials and methodsA total of 581 subjects were randomized in this double-blind (DB) placebo-controlled trial (NCT00712920) that compared 0.10% (1,096 μg daily) and 0.15% AZE (1,644 μg daily) to the placebo in PAR patients. The study consisted of a 7-day single-blind placebo lead-in period and a 28-day DB treatment period. The primary endpoint was the change from baseline in the 12-h reflective total nasal symptom score (rTNSS) for the entire 28-day study period of 0.15% AZE, two sprays per nostril BID compared to the placebo. The efficacy and safety of 0.15% AZE were compared to the placebo.ResultsLeast square (LS) mean improvement from baseline in the morning (AM) and evening (PM) combined rTNSS was statistically significant for the 0.15% AZE group (p = 0.04) compared to the placebo group. LS mean improvement from baseline in the AM and PM combined rTNSS was 4.10 (4.26) units for 0.15% AZE and 3.81 (3.99) for 0.10% AZE. For individual symptoms, there was a statistically significant change in the LS mean (p = 0.04) improvement from baseline on the 12-h reflective assessment for the 0.15% AZE group for runny nose. Further numerical improvements were shown for itchy nose, nasal congestion, runny nose, and sneezing compared to the placebo. No deaths or serious adverse events related to the study medication were reported.ConclusionThe present formulation of 0.15% AZE is safe and effective in relieving PAR symptoms. It effectively relieves nasal and non-nasal symptoms. Clinical Trial RegistrationClinicalTrials.gov, identifier: NCT00712920.

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Section: Discussionmentioning

confidence: 99%

“…However, AZE showed comparable efficacy for all other nasal and ocular symptoms ( 4 ). As PAR patients require long-term medication compared to SAR patients, 0.15% AZE could be a safe option for children and patients with glaucoma and cataracts ( 22 ).…”

Section: Discussionmentioning

confidence: 99%