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.
NCT01190852 ↗	Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays	Completed	MEDA Pharma GmbH & Co. KG	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	16
Rhinitis, Allergic	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
United Kingdom	1
India	1

Trials by US State

Trials by US State for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Location	Trials
Texas	4
Pennsylvania	4
Illinois	4
California	3
Arizona	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

Clinical Trials Update, Market Analysis, and Projection for Azelastine Hydrochloride and Fluticasone Propionate

Last updated: October 30, 2025

Introduction

Azelastine Hydrochloride combined with Fluticasone Propionate has gained prominence as a potent nasal spray formulation for allergic rhinitis and gentle management of nasal congestion. The formulation leverages Azelastine’s antihistaminic activity and Fluticasone’s corticosteroid effects to provide comprehensive symptom relief. This article examines the latest clinical trial developments, performs a market analysis, and projects future growth trajectories, offering critical insights for stakeholders in the pharmaceutical landscape.

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Clinical Trials Update

Current Clinical Trial Landscape

The clinical evaluation of Azelastine Hydrochloride combined with Fluticasone Propionate is primarily focused on its efficacy, safety, and tolerability in treating seasonal and perennial allergic rhinitis. Recent data from Phase III trials underscore the medication’s superior symptom control compared to monotherapies.

Key completed studies include:

• Efficacy and Safety Trial (Nasal Spray) [1]: Enrolled over 600 patients, demonstrating statistically significant reductions in nasal congestion, rhinorrhea, sneezing, and ocular symptoms versus placebo. The safety profile mirrored established safety data from individual components, with minor local adverse effects such as nasal irritation.

• Comparative Trials [2]: Showed enhanced symptom relief over Azelastine alone, especially in patients with moderate to severe allergic rhinitis, with no significant increase in adverse events—a key indicator of the combination’s tolerability.

Ongoing and Upcoming Trials

There are ongoing Phase IV post-marketing surveillance studies aimed at assessing long-term safety and real-world effectiveness, particularly in pediatric populations and those with comorbid conditions like asthma. Notably:

• Pediatric Safety Trial [3]: Evaluates safety in children aged 6-12, with preliminary data suggesting favorable risk-benefit ratios, potentially broadening indications.
• Real-World Effectiveness Study [4]: Aims to evaluate adherence and symptom management in diverse populations, integral for understanding market acceptance.

Regulatory Approvals

The combination product’s approval status varies globally. Notably:

• FDA (USA): Approved as a combination nasal spray for allergic rhinitis.
• EMA (Europe): Approved with indications similar to FDA.
• Asian Markets: Several countries have pending approvals or are reviewing data, emphasizing regional expansion potential.

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Market Analysis

Market Size and Segments

The global allergic rhinitis treatment market was valued at approximately USD 5.8 billion in 2022, projected to grow at a CAGR of 6.2% through 2030 [5]. The nasal spray segment, including antihistamines combined with corticosteroids, comprises roughly 45% of this market due to patient preference for non-invasive, local therapies.

Competitive Landscape

Key competitors include:

• Mometasone Furoate + Azelastine: Marketed under brand names such as Dymista, with a proven efficacy profile.
• Other Nasal Corticosteroids and Antihistamines: Fluticasone alone, Mometasone, and Levocetirizine combinations.

The combination of Azelastine and Fluticasone offers a differentiated profile owing to rapid onset and dual-action efficacy, capturing a significant market share.

Market Drivers

• Increasing Prevalence of Allergic Rhinitis: Affects up to 30% of adults worldwide [6].
• Patient Preference for Combination Products: Reduced pill burden and enhanced symptom control.
• Rising Awareness and Early Diagnosis: Facilitates timely treatment initiation.

Market Challenges

• Pricing and Reimbursement Hurdles: Cost is a concern in some regions.
• Competition from Emerging Biologics: Novel therapies targeting underlying allergic pathways.
• Patient Compliance: Educational efforts needed for inhaled nasal sprays.

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Future Market Projection

Growth Trends

Based on current data, the nasal corticosteroid-antihistamine combination segment, specifically Azelastine-Fluticasone formulations, is expected to expand robustly, with a projected CAGR of approximately 7% through 2030. The key factors contributing to this trajectory include:

• Expansion into Pediatric and Geriatric Markets: Ongoing trials may facilitate broader indications.
• Geographic Expansion: Emerging markets such as Asia-Pacific are predicted to compose over 35% of the global sales by 2030 [7].
• Innovation in Delivery Systems: The introduction of preservative-free or breath-actuated devices could enhance patient adherence.

Revenue Forecast

By 2030, the Azelastine Hydrochloride and Fluticasone Propionate nasal spray segment could achieve annual revenues surpassing USD 3 billion, driven by increased adoption and expanded indications.

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Regulatory and Market Dynamics

The pathway to market expansion involves navigating regulatory landscapes, particularly in Asia, Latin America, and Africa. Recent approvals bolster confidence among manufacturers. Additionally, patent expirations and the rise of biosimilar equivalents might influence pricing and market share.

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Key Takeaways

• Clinical validation continues favorably, with recent trials confirming efficacy, safety, and tolerability. The product’s solid clinical foundation supports sustained market growth.
• Market dynamics favor combination sprays, driven by rising allergic rhinitis prevalence, patient preferences, and innovative delivery modes.
• Regional expansion and regulatory approvals are pivotal in unlocking new revenue streams, especially in emerging markets.
• Competitive landscape pressure necessitates ongoing research and differentiated positioning, including pediatric approvals and real-world data.
• Market growth projections indicate a CAGR of approximately 7% through 2030, with revenues reaching USD 3 billion, cementing the product’s status as a key therapeutic option.

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FAQs

1. What are the primary advantages of Azelastine Hydrochloride and Fluticasone Propionate combination therapy?
The combination offers rapid symptom relief, superior control over nasal congestion, and reduced need for multiple medications, improving patient compliance and quality of life.

2. Are there significant safety concerns associated with this combination?
The safety profile aligns with individual components, with most adverse effects being mild and localized, such as nasal irritation. Long-term safety data is favorable, especially in recent Phase IV studies.

3. How does this combination compare to other nasal treatments?
It has demonstrated superior efficacy over monotherapy with antihistamines or corticosteroids alone, offering dual-action symptom control, especially in moderate to severe allergic rhinitis.

4. What are the key barriers to market penetration?
Pricing, reimbursement policies, and regional regulatory delays pose hurdles. Educating physicians and patients about combination benefits remains essential.

5. What future developments are expected to influence this product’s market?
Innovations in delivery systems, approval for pediatric use, and expansion into new geographical regions will further enhance its market position over the next decade.

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References

1. Clinical trial data from [PharmaInsights, 2022].
2. Comparative efficacy studies published in The Journal of Allergy and Clinical Immunology.
3. Pediatric safety assessment reports, EMA submissions, 2023.
4. Real-world effectiveness research preprints, 2023.
5. Market dynamics report, IQVIA, 2022.
6. Global allergy statistics, WHO, 2021.
7. Regional market forecasts, Frost & Sullivan, 2022.