CLINICAL TRIALS PROFILE FOR AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

All Clinical Trials for Azelastine Hydrochloride And Fluticasone Propionate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00651118 ↗	A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	2008-03-01	The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
NCT00660517 ↗	A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	2007-12-01	The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
NCT00740792 ↗	A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	2008-08-01	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)
NCT00883168 ↗	A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	2009-04-01	The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).
NCT01190852 ↗	Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays	Completed	ClinResearch, GmbH	Phase 1	2010-08-01	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.
NCT01190852 ↗	Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays	Completed	Prolytic GmbH	Phase 1	2010-08-01	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.

Clinical Trial Conditions for Azelastine Hydrochloride And Fluticasone Propionate

Condition Name

Condition Name for Azelastine Hydrochloride And Fluticasone Propionate
Intervention	Trials
Seasonal Allergic Rhinitis	10
Allergic Rhinitis	5
Allergy	1
Asthma, Allergic	1

Condition MeSH

Condition MeSH for Azelastine Hydrochloride And Fluticasone Propionate
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	11
Rhinitis, Allergic, Perennial	1

Clinical Trial Locations for Azelastine Hydrochloride And Fluticasone Propionate

Trials by Country

Trials by Country for Azelastine Hydrochloride And Fluticasone Propionate
Location	Trials
United States	65
Canada	3
Germany	2
India	1
United Kingdom	1

Trials by US State

Trials by US State for Azelastine Hydrochloride And Fluticasone Propionate
Location	Trials
Illinois	4
Texas	4
Pennsylvania	4
Ohio	3
North Carolina	3

Clinical Trial Progress for Azelastine Hydrochloride And Fluticasone Propionate

Clinical Trial Phase

Clinical Trial Phase for Azelastine Hydrochloride And Fluticasone Propionate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Azelastine Hydrochloride And Fluticasone Propionate
Clinical Trial Phase	Trials
Completed	9
Unknown status	3
Not yet recruiting	2

Clinical Trial Sponsors for Azelastine Hydrochloride And Fluticasone Propionate

Sponsor Name

Sponsor Name for Azelastine Hydrochloride And Fluticasone Propionate
Sponsor	Trials
Meda Pharmaceuticals	4
MEDA Pharma GmbH & Co. KG	4
ClinResearch, GmbH	2

Sponsor Type

Sponsor Type for Azelastine Hydrochloride And Fluticasone Propionate
Sponsor	Trials
Industry	14
Other	10

Azelastine Hydrochloride and Fluticasone Propionate: Clinical Trials, Market Analysis, and Projections

Introduction

Azelastine hydrochloride and fluticasone propionate, combined in the nasal spray Dymista, have been a significant advancement in the treatment of allergic rhinitis. Here, we will delve into the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials Overview

Approval and Initial Trials

The FDA approved Dymista in 2012 for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years and older. The approval was based on an extensive clinical development program, including four 2-week phase 3 efficacy and safety trials (MP-4001, MP-4002, MP-4004, and MP-4006) and a year-long safety trial (MP-4000)[1].

Trial Design and Outcomes

These trials employed a factorial design, evaluating the combination product (MP29-02) along with placebo and monotherapy comparators (azelastine hydrochloride and fluticasone propionate). The primary endpoint was the change from baseline in the reflective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period. Results showed statistically significant improvements for Dymista compared to placebo and each monotherapy component[1].

Pediatric Studies

Following the initial approval, additional studies were conducted to expand the indication to children. Studies MP-4007 and MP-4008, mandated under the Pediatric Research Equity Act (PREA), evaluated the safety and efficacy of Dymista in children aged 4 to 11 years. These studies led to the approval of Dymista for use in children aged 6 to 11 years in February 2015[4].

Safety Profile

Postmarketing Surveillance

The pediatric postmarketing safety profile of Dymista was reviewed, and no new safety signals were identified. The review included adverse event reports from the FDA Adverse Event Reporting System (FAERS) database, which did not reveal any significant safety concerns[4].

Adverse Events

While some adverse events such as dysphagia, panic attack, and cellulitis were reported, they were not deemed to be new safety signals. The overall safety profile of Dymista has been found to be acceptable, with adverse events consistent with those of the individual components[4].

Market Analysis

Allergic Rhinitis Market

Allergic rhinitis is a significant health issue, with direct medical expenses in the USA amounting to around $3.4 billion annually. The market for treatments is competitive, with various combinations of antihistamines and corticosteroids available[2].

Market Share and Competition

Dymista competes with other combination therapies such as Fluticasone Furoate + Oral Antihistamine and Mometasone + Oral Antihistamine. Budget impact analyses suggest that Dymista can be a cost-effective option, especially when considering the convenience of a single product over multiple therapies[2].

Budget Impact Analysis

A budget impact analysis in the Kingdom of Saudi Arabia indicated that increasing the market share of Dymista could lead to a manageable increase in total healthcare expenditure. The analysis showed that Dymista compares favorably with dual and triple therapy combinations in terms of cost and efficacy[2].

Projections and Future Outlook

Market Growth

The market for allergic rhinitis treatments is expected to grow, driven by increasing prevalence and the need for effective, convenient treatments. Dymista, with its proven efficacy and safety, is well-positioned to capture a significant share of this growing market.

Expanding Indications

Future studies may focus on expanding the indication to younger children and exploring the use of Dymista in perennial allergic rhinitis. The ongoing pharmacovigilance and postmarketing studies will continue to monitor the safety profile, potentially leading to further approvals and market expansion[4].

Regulatory Environment

Regulatory approvals and compliance with international guidelines, such as those in Europe and Canada, will remain crucial for the continued success of Dymista. The product's chemical-pharmaceutical quality and manufacturing process have been validated according to relevant European/ICH guidelines, ensuring its quality and safety[5].

Key Takeaways

• Clinical Efficacy: Dymista has demonstrated significant efficacy in reducing symptoms of seasonal allergic rhinitis in both adults and children.
• Safety Profile: The safety profile of Dymista is acceptable, with no new safety signals identified in postmarketing surveillance.
• Market Position: Dymista is a competitive option in the allergic rhinitis market, offering a convenient single-product solution.
• Future Outlook: The market for allergic rhinitis treatments is expected to grow, with Dymista well-positioned to capture a significant share.

FAQs

What is Dymista, and how is it used?

Dymista is a nasal spray containing azelastine hydrochloride and fluticasone propionate, used for the relief of symptoms of seasonal allergic rhinitis. It is administered as one spray per nostril twice daily.

What are the key components of Dymista?

Dymista contains 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation.

What age groups is Dymista approved for?

Dymista is approved for use in patients 6 years and older for the treatment of seasonal allergic rhinitis.

What were the outcomes of the clinical trials for Dymista?

Clinical trials showed statistically significant improvements in nasal symptom scores for Dymista compared to placebo and monotherapy components.

How does Dymista compare to other treatments in terms of cost?

Dymista is considered a cost-effective option when compared to other combination therapies, especially considering its convenience as a single product.

Sources

1. FDA Clinical Review: "202236 Azelastine HCl and Fluticasone propionate Clinical PREA"[1]
2. ISPOR Budget Impact Analysis: "A Budget Impact Analysis of Azelastine Hydrochloride/Fluticasone Propionate (AzeFlu) Nasal Spray Suspension for Patients with Allergic Rhinitis (AR) in the Kingdom of Saudi Arabia (KSA)"[2]
3. Health Canada Regulatory Decision Summary: "Regulatory Decision Summary for Dymista"[3]
4. FDA Safety Review: "Dymista (azelastine hydrochloride fluticasone propionate) Safety Review"[4]
5. Public Assessment Report: "Public Assessment Report - Azelastine/Fluticasonpropionaat Win Medica"[5]

Last updated: 2025-01-01