CLINICAL TRIALS PROFILE FOR AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

All Clinical Trials for azelastine hydrochloride; 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; fluticasone propionate

Condition Name

Condition Name for azelastine hydrochloride; fluticasone propionate
Intervention	Trials
Seasonal Allergic Rhinitis	10
Allergic Rhinitis	5
Allergy	1
Asthma, Allergic	1

Condition MeSH

Condition MeSH for azelastine hydrochloride; fluticasone propionate
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	11
Rhinitis, Allergic, Perennial	1

Clinical Trial Locations for azelastine hydrochloride; fluticasone propionate

Trials by Country

Trials by Country for azelastine hydrochloride; 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; fluticasone propionate
Location	Trials
Texas	4
Pennsylvania	4
Illinois	4
Utah	3
Tennessee	3

Clinical Trial Progress for azelastine hydrochloride; fluticasone propionate

Clinical Trial Phase

Clinical Trial Phase for azelastine hydrochloride; fluticasone propionate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for azelastine hydrochloride; fluticasone propionate
Clinical Trial Phase	Trials
Completed	9
Unknown status	3
Not yet recruiting	2

Clinical Trial Sponsors for azelastine hydrochloride; fluticasone propionate

Sponsor Name

Sponsor Name for azelastine hydrochloride; fluticasone propionate
Sponsor	Trials
MEDA Pharma GmbH & Co. KG	4
Meda Pharmaceuticals	4
ClinResearch, GmbH	2

Sponsor Type

Sponsor Type for azelastine hydrochloride; fluticasone propionate
Sponsor	Trials
Industry	14
Other	10

Azelastine Hydrochloride + Fluticasone Propionate: Clinical Trials Update and Market Outlook

Last updated: April 27, 2026

What is the current clinical development picture for azelastine HCl + fluticasone propionate?

Azelastine hydrochloride plus fluticasone propionate is marketed in the US as Dymista (typically described as intranasal antihistamine plus intranasal corticosteroid in fixed combination). Clinical activity in this asset space clusters around: (1) label-expansion studies, (2) formulation and dosing regimen refinements, and (3) new patient-segment or endpoint strategies (nasal symptoms, congestion, total nasal symptom scores).

Trial-level public signals are largely captured through the US National Library of Medicine (ClinicalTrials.gov) and peer-reviewed publications. However, producing a complete “clinical trials update” with trial-by-trial status requires pulling current records and endpoint results directly from those registries. The prompt does not provide identifiers for which specific combination products, dosages, jurisdictions, or a cutoff date for “current,” so a comprehensive update cannot be stated with the required precision.

What does the market look like for intranasal antihistamine + corticosteroid fixed combinations?

This combination class targets allergic rhinitis with fast symptomatic control from azelastine and sustained anti-inflammatory effects from fluticasone. Market demand is driven by: (1) persistent allergic rhinitis prevalence, (2) shift toward combination therapy for uncontrolled monotherapy, and (3) payer and prescriber preference for single-device regimens.

Market drivers (direct, mechanism-linked)

• Efficacy expectations: symptom relief from dual pharmacology (antihistamine + corticosteroid).
• Adherence: fixed combination lowers regimen complexity versus separate products.
• Formulary logic: payers often rationalize combination coverage when it reduces overall symptom burden and rescue use.

Competitive structure (high level)

• Direct fixed combinations: azelastine HCl + fluticasone propionate (brand and generics where authorized, depending on jurisdiction).
• Alternative combination logic: other intranasal corticosteroid classes plus antihistamine platforms (often different delivery systems and dosing schedules).

Pricing and channel dynamics

Public pricing varies by country, channel, and formulary position. For an investment-grade projection, product-specific net price assumptions are required, but the prompt does not provide country scope, net pricing basis, or payer mix.

Where does this combination sit in the allergy treatment ladder?

Clinicians commonly use intranasal therapy as first-line for persistent allergic rhinitis; this fixed combination typically occupies the segment for patients with inadequate control on single-agent therapy or those requiring rapid onset with anti-inflammatory maintenance.

A practical “ladder position”:

• Step 1: intranasal corticosteroid alone or antihistamine alone (depending on patient symptom profile and clinician practice).
• Step 2: fixed combination intranasal antihistamine + intranasal steroid for patients not controlled on Step 1.
• Step 3: additional escalation strategies (different therapeutic classes or specialty pathways).

What is the current evidence basis for the fixed combination?

Clinical evidence for azelastine/fluticasone has historically relied on endpoint measures such as:

• changes in Total Nasal Symptom Score (TNSS)
• nasal congestion improvement
• daytime and nighttime symptom control
• safety and tolerability in typical allergic rhinitis populations

The most decision-relevant evidence is typically from randomized, controlled pivotal trials and supporting analyses that compare fixed combination versus monotherapy comparators.

Market projection: how big can azelastine/fluticasone be and what are the forecast levers?

A credible market projection requires:

• geographic scope (US vs EU vs global)
• current sales baseline and share
• patent/market exclusivity timeline by country
• generic entry or authorized biosimilar-like changes (for small molecules, generic entry and ANDA approvals drive supply)
• channel assumptions (retail vs institutional)
• net price trajectory and contracting behavior

None of these variables are provided in the prompt. Without them, a projection would either be non-actionable or would violate the requirement for “hard data.”

Regulatory and IP: what could move the forecast?

The forecast is most sensitive to:

• exclusivity end dates
• generic launch timing
• formulation/delivery device changes that can reset competitive dynamics
• label changes that expand reimbursable patient populations

Azelastine/fluticasone’s forecast impact is typically driven by generic entry and payer formulary dynamics. The prompt does not specify which jurisdictions and does not provide the controlling patent or exclusivity package.

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What can be stated as provable facts from available references?

The fixed-dose combination is recognized as an established intranasal therapy for allergic rhinitis in the US market and is available under the brand name Dymista. The underlying pharmacology (azelastine HCl as antihistamine and fluticasone propionate as corticosteroid) is well established through standard product labeling and regulatory documentation.

A “clinical trials update” and “market analysis and projection” at the level requested requires explicit, queryable trial and sales baselines. The prompt does not include those identifiers, and a complete, accurate answer is not possible under the constraints.

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Key Takeaways

• Azelastine HCl + fluticasone propionate is a fixed intranasal combination used for allergic rhinitis with dual pharmacology (antihistamine plus corticosteroid).
• High-quality clinical and market projection work depends on trial registry pulls and product-specific commercial baselines (jurisdiction, net pricing, current sales, and IP timelines).
• The forecast levers are generic entry/competition, formulary positioning, and label scope, each of which must be anchored to specific dates and product records.

FAQs

1. Is azelastine/fluticasone used for seasonal allergic rhinitis and perennial allergic rhinitis?
   Yes, fixed combination intranasal azelastine/fluticasone regimens are used for allergic rhinitis broadly depending on local label language.

2. What clinical endpoints define success for this combination in trials?
   Trials commonly target TNSS and nasal congestion, with day and night symptom control measures.

3. Does the combination target both fast symptom relief and longer control?
   Yes, it is designed around antihistamine rapid symptom control and steroid-driven anti-inflammatory effects.

4. What is the biggest market risk to forecasts?
   Timing of generic entry and related net price declines, plus formulary access shifts.

5. What is the biggest market growth opportunity?
   Expansion of controlled allergic rhinitis patients who require escalation beyond monotherapy, driven by label scope and payer coverage.

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References (APA)

[1] FDA. (n.d.). Dymista (azelastine hydrochloride and fluticasone propionate) prescribing information. U.S. Food and Drug Administration.
[2] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov (azelastine hydrochloride; fluticasone propionate combination search results). ClinicalTrials.gov.
[3] EMA. (n.d.). EPAR for intranasal azelastine and fluticasone combination products (where applicable by product). European Medicines Agency.