CLINICAL TRIALS PROFILE FOR FLONASE ALLERGY RELIEF

All Clinical Trials for FLONASE ALLERGY RELIEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00119015 ↗	The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis	Terminated	Merck Sharp & Dohme Corp.	Phase 4	2005-07-01	Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).
NCT00119015 ↗	The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis	Terminated	University of Chicago	Phase 4	2005-07-01	Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).
NCT00275561 ↗	Topical Steroid Treatment for Eosinophilic Esophagitis	Completed	Mayo Clinic	Phase 2	2005-11-01	This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food. Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.
NCT00385463 ↗	Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo	Withdrawn	GlaxoSmithKline	N/A	2006-04-01	The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and are currently available by prescription at your drug store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and one is for treatment of both SAR and asthma. In addition, you will also receive one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may experience throughout the study. The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
NCT00385463 ↗	Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo	Withdrawn	Creighton University	N/A	2006-04-01	The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and are currently available by prescription at your drug store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and one is for treatment of both SAR and asthma. In addition, you will also receive one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may experience throughout the study. The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
NCT00550550 ↗	Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)	Completed	ALK-Abelló A/S	Phase 3	2007-11-01	The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
NCT00550550 ↗	Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-11-01	The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.

Clinical Trial Conditions for FLONASE ALLERGY RELIEF

Condition Name

Condition Name for FLONASE ALLERGY RELIEF
Intervention	Trials
Allergic Rhinitis	5
Seasonal Allergic Rhinitis	4
Rhinitis	2
Conjunctivitis	2

Condition MeSH

Condition MeSH for FLONASE ALLERGY RELIEF
Intervention	Trials
Rhinitis	14
Rhinitis, Allergic	13
Rhinitis, Allergic, Seasonal	5
Conjunctivitis	4

Clinical Trial Locations for FLONASE ALLERGY RELIEF

Trials by Country

Trials by Country for FLONASE ALLERGY RELIEF
Location	Trials
United States	25
Ireland	1
Canada	1

Trials by US State

Trials by US State for FLONASE ALLERGY RELIEF
Location	Trials
Massachusetts	3
California	3
New York	2
Missouri	2
Florida	2

Clinical Trial Progress for FLONASE ALLERGY RELIEF

Clinical Trial Phase

Clinical Trial Phase for FLONASE ALLERGY RELIEF
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FLONASE ALLERGY RELIEF
Clinical Trial Phase	Trials
Completed	16
Terminated	3
Recruiting	2

Clinical Trial Sponsors for FLONASE ALLERGY RELIEF

Sponsor Name

Sponsor Name for FLONASE ALLERGY RELIEF
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
University of Chicago	2
GlaxoSmithKline	2

Sponsor Type

Sponsor Type for FLONASE ALLERGY RELIEF
Sponsor	Trials
Industry	16
Other	13
NIH	1

FLONASE ALLERGY RELIEF Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the Clinical Trial Status of Flonase Allergy Relief?

Flonase Allergy Relief, a nasal spray containing fluticasone propionate, has a long-established presence in the allergy medication market. The formulation’s regulatory approval is based on multiple clinical studies demonstrating safety and efficacy for allergic rhinitis.

As of the latest available data, no new advanced-phase clinical trials for Flonase label expansion or new indication approvals are underway or registered in clinical trial registries such as clinicaltrials.gov. The product’s core indication remains treatment of perennial and seasonal allergic rhinitis. It is classified as a drug already approved for OTC sales in both the U.S. and other markets, with its original approval based on pivotal trials conducted more than a decade ago.

However, ongoing pharmacovigilance and real-world evidence collection continue to support its safety profile. No recent updates indicate new clinical trial activity for formulation modifications or novel uses.

How Does Market Data for Flonase Allergy Relief Look?

Market Size and Revenue

Flonase is a leading OTC intranasal corticosteroid with significant market penetration. In 2022, the global allergy drugs market was valued at approximately $13 billion, with intranasal corticosteroids accounting for nearly 50%, or about $6.5 billion. Fluticasone-based products held a dominant share within this segment—estimated at 40% of intranasal corticosteroid sales globally.

In the U.S., Flonase accounted for around $750 million in annual revenue by 2022. Sales are driven by its well-established OTC status, wide distribution, and consumer recognition.

Competitive Landscape

Key competitors include:

• Rhinocort (budesonide)
• Nasacort (triamcinolone)
• Xhance (fluticasone nasal spray, prescription)

Market share distribution positions Flonase as the leading OTC nasal spray, holding approximately 37% of the US allergy nasal spray market.

Regulatory Environment

Statute and policy changes favor OTC availability. The FDA approved Flonase for OTC use in 2014, facilitating increased consumer access and boosting sales.

What Are the Market Projections for Flonase Allergy Relief?

Growth Drivers

• Increasing allergy prevalence: Based on CDC data, hay fever and allergic rhinitis affect around 20% of Americans, with rising incidence globally.
• Consumer preference: OTC availability and favorable consumer reviews drive repeat purchases.
• Prescriptions to OTC switches: The success of Flonase’s OTC transition serves as a blueprint for potential new indications or formulations.

Forecasts

Analysts project the global market for Flonase and similar nasal corticosteroids to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, reaching an estimated $8.2 billion by 2027.

In North America, the market is expected to grow at around 5% annually, driven by increased allergy awareness and OTC sales expansion.

Potential for Market Share Expansion

• Incumbent dominance may be challenged by new formulations offering reduced side effects or extended duration.
• Consumer shifts towards natural or alternative remedies may influence niche segments but are unlikely to significantly impact market leaders presently.

Are There Opportunities for New Indications or Delivery Methods?

While no current clinical trials target new indications for Flonase, regulatory strategies such as patent extensions through formulation innovations or combination products could support revenue growth. Also, emerging drug delivery technologies—such as micro-dose pumps or novel spray devices—may enhance user experience.

Summary

Flonase Allergy Relief remains a cornerstone in allergy management with a well-established safety profile and stable market presence. Despite no recent clinical trial activity targeting new indications, its market continues to grow, driven by allergy prevalence, OTC accessibility, and consumer demand. The outlook suggests incremental growth, with potential expansion through formulation innovations or added indications.

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Key Takeaways

• No current clinical trials target new uses or formulations of Flonase.
• The drug commands a dominant position in the OTC allergy nasal spray market.
• The market is expected to reach over $8 billion globally by 2027, growing at 4-6% CAGR.
• Regulatory and consumer trends favor steady growth in North American markets.
• Opportunities exist in formulation innovation and delivery technology.

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FAQs

1. Are there any new clinical trials planned for Flonase?
No, recent registry data show no active or upcoming trials focusing on Flonase for new indications or formulations.

2. What is Flonase’s primary mode of action?
It delivers corticosteroids locally to the nasal mucosa, reducing inflammation associated with allergic rhinitis.

3. Can Flonase be used for other conditions?
Currently approved for allergic rhinitis; off-label use for sinus congestion has been reported but lacks regulatory approval.

4. How does Flonase compare to other nasal sprays?
It has a larger market share than rivals like Nasacort or Rhinocort, partly due to its OTC status and extensive marketing.

5. What are the growth prospects for Flonase in emerging markets?
Growing allergy prevalence, improving healthcare infrastructure, and regulatory approvals support expansion into regions such as Asia-Pacific and Latin America.

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References

[1] MarketWatch, "Global Allergy Drugs Market," 2022.
[2] CDC, "Prevalence of Allergic Rhinitis," 2022.
[3] FDA, "OTC Consultation for Flonase," 2014.