DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Azelastine (Azelastine Hydrochloride) - Summary

 
 



AZELASTINE SUMMARY

Azelastine Hydrochloride
Nasal Spray, 137 mcg
IN-0294-01 Rev. 5/10
For Intranasal Use Only

Azelastine Hydrochloride Nasal Spray, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration.

Azelastine Hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.


See all Azelastine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Azelastine

MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. [2012]
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR)...

Two-week comparison study of olopatadine hydrochloride nasal spray 0.6% versus azelastine hydrochloride nasal spray 0.1% in patients with vasomotor rhinitis. [2011.03]
Olopatadine hydrochloride nasal spray 0.6% (OLO) and azelastine nasal spray 137 micrograms (AZE) are effective in treating allergic rhinitis and AZE is indicated for nonallergic vasomotor rhinitis (VMR). This study evaluates the relative safety and efficacy of OLO and AZE in patients with VMR.

Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. [2010.08]
BACKGROUND: A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone. OBJECTIVE: To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray... CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00660517. Copyright 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Comparison of azelastine versus triamcinolone nasal spray in allergic and nonallergic rhinitis. [2010.01]
BACKGROUND: Intranasal antihistamine has not been thoroughly studied in the treatment of rhinitis of different etiologies. This study was designed to show the comparative efficacy of nasal antihistamine and nasal corticosteroid in patients with allergic rhinitis (AR) and nonallergic rhinitis (NAR)... CONCLUSION: In this first comparative demonstration, AZENS appears to be as effective as triamcinolone in symptom scores, nPIFR, ESS, and HRQoL, equally in AR and NAR.

Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. [2010]
nasal spray and fluticasone nasal spray... CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided

more studies >>

Clinical Trials Related to Azelastine

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays [Recruiting]
The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i. e. AZE alone; REF).

The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Azelastine Fluticasone Combination vs. Fluticasone [Not yet recruiting]
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i. e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.

Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays [Recruiting]
The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i. e. FLU alone in the MP29-02 vehicle; REF).

The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product, Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis [Recruiting]
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat seasonal allergies to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat seasonal allergies to placebo.

more trials >>

Reports of Suspected Azelastine Side Effects

Oesophageal Ulcer (3)Dysphagia (3)Regurgitation (2)Oesophageal Injury (2)Merycism (2)Odynophagia (2)Product Substitution Issue (1)Drug Ineffective (1)Product Packaging Quantity Issue (1)Headache (1)more >>


Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014