Ophthalmic Solution, 0.5%
Azelastine Hydrochloride Ophthalmic Solution, 0.5% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H1-receptor antagonist for topical administration to the eyes.
Azelastine Hydrochloride Ophthalmic Solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
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. 
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. 
nasal spray and fluticasone nasal spray... CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided
Clinical Trials Related to Azelastine
Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays [Completed]
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.
Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays [Completed]
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
A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies [Completed]
The purpose of this study is to determine if two allergy medications (formulated azelastine
and fluticasone product) are more effective than placebo or either medication alone
(azelastine or fluticasone)
Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis [Completed]
The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide +
Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients
with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis [Completed]
This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of
intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in
subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead
electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout
the study. Nasal examination, symptom scores, and allergen challenge assessments will also
be performed at various time points throughout the study.
Reports of Suspected Azelastine Side Effects
Oesophageal Ulcer (3),
Oesophageal Injury (2),
Product Substitution Issue (1),
Drug Ineffective (1),
Product Packaging Quantity Issue (1),
Headache (1), more >>
Page last updated: 2013-02-10