CLINICAL TRIALS PROFILE FOR DYMISTA

All Clinical Trials for Dymista

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01794741 ↗	3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis	Completed	Meda Pharmaceuticals	Phase 3	2013-02-01	This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
NCT01915823 ↗	Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)	Completed	Meda Pharmaceuticals	Phase 3	2013-07-01	The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to
NCT02238353 ↗	AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)	Unknown status	Universitaire Ziekenhuizen Leuven	Phase 4	2014-10-01	Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.
NCT02249663 ↗	Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™	Unknown status	Teva Pharmaceuticals USA	Phase 3	2014-08-01	To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.
NCT02279563 ↗	A Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymista™ Nasal Spray (Meda Pharmaceuticals, Inc.) in the Treatment of Seasonal Allergic Rhinitis	Unknown status	Apotex Inc.	Phase 2	2013-12-01	This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal spray.
NCT02402465 ↗	Evaluating Factors Involved in Dymista's Superior Clinical Efficacy to Fluticasone Propionate in the Treatment of Seasonal Allergic Rhinitis	Unknown status	University of Chicago	Phase 4	2015-02-01	Dymista, a combined product containing the antihistamine azelastine and the intranasal steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of efficacy not only occurs at the initiation of treatment, but persists for its duration. The mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on examining the effects of Dymista on the dynamics of the allergic response in man using nasal provocation with antigen. The investigators will study the relationship between symptoms, physiology, cells and mediators.
NCT02883439 ↗	Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate	Withdrawn	MEDA Pharma GmbH & Co. KG	N/A	2016-08-01	The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application. This may provide a rational basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has demonstrated the efficacy of the twice-daily treatment; however, so far, no data are available on the local tissue concentrations of MP29-02 after topical application.

Clinical Trial Conditions for Dymista

Condition Name

Condition Name for Dymista
Intervention	Trials
Seasonal Allergic Rhinitis	6
Allergic Rhinitis	5
Allergy	1
Asthma, Allergic	1

Condition MeSH

Condition MeSH for Dymista
Intervention	Trials
Rhinitis, Allergic	12
Rhinitis	12
Rhinitis, Allergic, Seasonal	7
Rhinitis, Allergic, Perennial	1

Clinical Trial Locations for Dymista

Trials by Country

Trials by Country for Dymista
Location	Trials
United States	41
China	18
Canada	2
Belgium	2
United Kingdom	1

Trials by US State

Trials by US State for Dymista
Location	Trials
Illinois	3
Pennsylvania	3
Kentucky	2
Indiana	2
Georgia	2

Clinical Trial Progress for Dymista

Clinical Trial Phase

Clinical Trial Phase for Dymista
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Dymista
Clinical Trial Phase	Trials
Completed	5
Unknown status	4
Not yet recruiting	1

Clinical Trial Sponsors for Dymista

Sponsor Name

Sponsor Name for Dymista
Sponsor	Trials
MEDA Pharma GmbH & Co. KG	3
Meda Pharmaceuticals	2
University of Dundee	1

Sponsor Type

Sponsor Type for Dymista
Sponsor	Trials
Industry	9
Other	6

DYMISTA (azelastine hydrochloride 137 mcg / fluticasone propionate 50 mcg per spray): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is DYMISTA and how is it positioned clinically?

DYMISTA is a fixed-dose intranasal combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray (ASTEPRO/azelastine + steroid combination class; used for nasal symptoms of allergic rhinitis). The product is commonly positioned as a single-device combination intended to control both:

• Histamine-mediated symptoms (azelastine)
• Inflammatory symptoms (fluticasone)

Across labeling and practice, DYMISTA is used for allergic rhinitis (with symptom control spanning congestion, rhinorrhea, sneezing, and itching). The clinical value proposition in market materials is the ability to deliver steroid and antihistamine action from one dosing regimen rather than separate products.

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What is the clinical trial update for DYMISTA?

A complete, up-to-date “trial-by-trial” clinical pipeline update requires specific registry matching (NCT identifiers, sponsor, status, and publication dates) and access to full trial listings. No such trial-level dataset is provided in the prompt, and producing a definitive update without it would risk factual error.

Result: no clinical-trials update can be produced here.

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How big is the DYMISTA market today?

A defensible current-market size and segmentation for DYMISTA requires:

• Total category size for intranasal antihistamine/steroid combinations
• Country-level adoption and payer coverage
• Share versus branded competitors and generics
• Price trajectory and sales trend evidence (typically from IQVIA, GlobalData, or company filings)

No market sizing inputs, regional breakdowns, or sales figures are included in the prompt, and without sourced numbers the analysis would be non-actionable.

Result: no quantified market analysis or current-size call can be produced here.

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What does market projection look like for DYMISTA?

Projections require at minimum:

• Historical sales curve and drivers (formulary wins/losses, promotion, channel shift)
• Forecast assumptions tied to underlying category growth and competitive pressure
• Patent/brand trajectory (for combination products, market evolution is often tied to exclusivity windows and generic entry patterns)

No historical sales or competitive entry dates are supplied, so any projection would be speculative.

Result: no projection can be produced here.

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What competitive and lifecycle factors typically shape intranasal combination demand?

Even without numeric sizing, decision-grade market drivers for intranasal antihistamine/steroid combinations generally fall into four buckets that investors and R&D teams track:

Adoption drivers

• Symptom coverage: combination regimens reduce the need to stack therapies for breakthrough symptoms.
• Time-to-control: azelastine’s onset supports faster relief than steroid-only approaches in many patient journeys.
• Adherence: single-device combination dosing tends to improve persistence versus multiple bottles.

Reimbursement and access drivers

• Formulary positioning: preferred status in payer formularies can expand share quickly.
• Step therapy: plans that require antihistamine trial before steroid combinations can slow conversion.
• Copay strategy: net realized price is highly sensitive to preferred-tier placement.

Competitive pressure

• Brand-to-generic dynamics: intranasal products face generic competitive sets depending on active ingredient patent status.
• Device equivalence: spray characteristics and patient preference influence switch rates at refill.

Safety and tolerability

• Local adverse events: epistaxis and irritation profiles affect persistence.
• Patient selection: comorbidities (e.g., concurrent sinus disease) and severity drive repeat use.

These drivers determine whether a branded combination maintains share once competing options expand.

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Actionable business framework (non-quantified)

For business professionals evaluating DYMISTA from an R&D and investment lens, the most decision-relevant workstreams typically are:

1. Regulatory and exclusivity audit
   • Map branded indication scope and any formulation/device patents (and whether they protect the exact fixed-dose combination).
2. Trial evidence consolidation
   • Build a clinical evidence dossier that links outcomes to payer-relevant endpoints (symptom control, rescue use, onset).
3. Competitive landscape mapping
   • Identify direct competitors (same drug class and combination approach) and adjacent comparators (steroid monotherapy, antihistamine monotherapy).
4. Payer and channel interrogation
   • Determine formulary status by segment and whether adoption is limited by step therapy or copay.

This framework is the basis for a quantitative market model, but the prompt does not supply the data needed to populate it.

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Key Takeaways

• DYMISTA is a fixed-dose intranasal combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray for allergic rhinitis symptom control.
• A trial-by-trial clinical update cannot be produced from the information provided.
• A quantified market analysis and forecast cannot be produced from the information provided.
• Competitive demand is shaped by adherence, time-to-control, payer access, and local tolerability; these inputs are required to build a numerical projection.

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FAQs

1) What is DYMISTA’s active ingredient combination?

DYMISTA contains azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray.

2) What condition does DYMISTA treat?

DYMISTA is indicated for nasal symptoms of allergic rhinitis.

3) Is DYMISTA a single-device combination or separate products?

It is a single fixed-dose intranasal combination product.

4) What endpoints usually matter most for payer decisions in intranasal allergy therapy?

Symptom control, time to relief, and rescue-medication or adherence-related outcomes are typically evaluated.

5) What are the main market drivers for intranasal antihistamine-steroid combinations?

Formulary placement, step-therapy requirements, net realized price, patient adherence, and local tolerability.

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References

[1] U.S. Food and Drug Administration. Dymista (azelastine hydrochloride and fluticasone propionate) prescribing information.