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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR FLONASE ALLERGY RELIEF


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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↗ Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo Withdrawn GlaxoSmithKline N/A 2006-04-01 The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flonase Allergy Relief

Condition Name

Condition Name for Flonase Allergy Relief
Intervention Trials
Allergic Rhinitis 5
Seasonal Allergic Rhinitis 4
Conjunctivitis 2
Allergic Conjunctivitis 2
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Condition MeSH

Condition MeSH for Flonase Allergy Relief
Intervention Trials
Rhinitis 14
Rhinitis, Allergic 13
Rhinitis, Allergic, Seasonal 5
Conjunctivitis 4
[disabled in preview] 0
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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
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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
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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
[disabled in preview] 7
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Clinical Trial Status

Clinical Trial Status for Flonase Allergy Relief
Clinical Trial Phase Trials
Completed 16
Terminated 3
Withdrawn 2
[disabled in preview] 3
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Clinical Trial Sponsors for Flonase Allergy Relief

Sponsor Name

Sponsor Name for Flonase Allergy Relief
Sponsor Trials
Merck Sharp & Dohme Corp. 7
Stanford University 2
ALK-Abelló A/S 2
[disabled in preview] 5
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Sponsor Type

Sponsor Type for Flonase Allergy Relief
Sponsor Trials
Industry 16
Other 13
NIH 1
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Flonase Allergy Relief: Clinical Trials, Market Analysis, and Projections

Introduction to Flonase Allergy Relief

Flonase Allergy Relief, containing the active ingredient fluticasone propionate, is a widely recognized and effective treatment for hay fever and other upper respiratory allergies. Initially approved as a prescription medication in 1994, it transitioned to an over-the-counter (OTC) treatment in 2014, marking a significant milestone in allergy treatment accessibility[2].

Clinical Trials and Efficacy

Historical Context and Prescription Era

During its prescription era, fluticasone propionate underwent extensive clinical trials that established its efficacy and safety profile. These trials demonstrated its ability to provide 24-hour non-drowsy relief from nasal and eye-related allergy symptoms, including runny nose, sneezing, itchy nose, nasal congestion, and itchy and watery eyes[2].

Recent Developments

In recent years, fluticasone propionate has continued to expand its indications. For instance, in 2024, the FDA approved fluticasone propionate nasal spray for the treatment of chronic rhinosinusitis without nasal polyps, based on findings from the phase 3 ReOpen clinical trial program. This approval highlighted the spray's effectiveness in delivering the steroid to the inflamed areas of the nasal cavity and sinuses[4].

Safety and Efficacy

Clinical trials have consistently shown that fluticasone propionate is well-tolerated and effective. However, like any medication, it comes with potential side effects such as stinging, sneezing, headaches, dry or irritated nose or throat, and nosebleeds. Despite these, its safety profile over 30 million accumulated patient years since its initial approval is robust[2].

Market Analysis

Current Market Status

The nasal spray market, which includes Flonase Allergy Relief, has experienced significant growth driven by the increasing prevalence of respiratory conditions and allergies. The market was valued at USD 24.15 billion in 2023 and is projected to reach USD 40.57 billion by 2031, growing at a CAGR of 6.70%[3].

Key Trends

Several trends are driving the growth of the nasal spray market:

  • Increasing Preference for Self-Administration: Patients are increasingly preferring self-administration therapies, which nasal sprays like Flonase Allergy Relief cater to effectively.
  • Innovations in Drug Formulations: Advances in drug formulations and delivery systems, such as microneedle technology, are enhancing the efficacy and comfort of nasal sprays.
  • Emergence of Novel Biologics: The use of biologic nasal sprays, which deliver large molecules directly to the bloodstream, is gaining traction.
  • Regulatory Support: Favorable regulatory environments and reimbursement policies are making nasal sprays more accessible[3].

Competitive Landscape

Flonase Allergy Relief is a leading product in the OTC nasal spray market. It was the first and only OTC nasal spray approved for the relief of all nasal and eye-related allergy symptoms. Other key players in the market include Pfizer, Johnson & Johnson, and Novartis, which are also investing heavily in research and development to expand their product portfolios[2][3].

Market Projections

Growth Drivers

The growth of Flonase Allergy Relief and the broader nasal spray market is driven by several factors:

  • Rising Prevalence of Allergies: Approximately 50 million people in the United States suffer from nasal allergies, leading to a high demand for effective treatments[2].
  • Unsatisfaction with Current Treatments: Despite the availability of various treatments, 50% of allergy sufferers report not being completely satisfied with their current methods, creating a significant market opportunity for Flonase Allergy Relief[2].
  • Convenience and Efficacy: The convenience of nasal sprays and their ability to provide targeted relief enhance patient compliance and satisfaction, further propelling market growth[3].

Marketing Strategies

Effective marketing strategies have played a crucial role in the success of Flonase Allergy Relief. For example, the "Greatest Season Ever" campaign, which leveraged the interest in baseball to remind consumers about the onset of allergy season, significantly boosted sales and engagement. This campaign highlighted the product's benefits through social media, YouTube, and mobile platforms, demonstrating the power of targeted marketing in the OTC allergy category[5].

Key Takeaways

  • Clinical Trials: Flonase Allergy Relief has a robust clinical trial history, with recent approvals expanding its indications to include chronic rhinosinusitis.
  • Market Growth: The nasal spray market is projected to grow significantly, driven by increasing allergy prevalence and innovations in drug formulations.
  • Competitive Advantage: Flonase Allergy Relief remains a leading product in the OTC nasal spray market due to its efficacy, convenience, and strong marketing strategies.
  • Future Prospects: With favorable regulatory environments and ongoing research, Flonase Allergy Relief is poised to continue dominating the market.

FAQs

What is Flonase Allergy Relief used for?

Flonase Allergy Relief is used to relieve symptoms of hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy nose, nasal congestion, and itchy and watery eyes[2].

How is Flonase Allergy Relief administered?

Initially, it is administered as 2 sprays in each nostril once daily for the first week, then 1 or 2 sprays in each nostril once daily as needed for weeks 2 through 6 months[1].

What are the potential side effects of Flonase Allergy Relief?

Potential side effects include stinging, sneezing, headaches, dry or irritated nose or throat, nosebleeds, and visual disturbances. It is also important to discontinue use if exposed to certain infections or if new symptoms develop[1].

Is Flonase Allergy Relief available over-the-counter?

Yes, Flonase Allergy Relief was approved for OTC sale in the United States in 2014, making it widely available without a prescription[2].

How does Flonase Allergy Relief compare to other allergy treatments?

Flonase Allergy Relief is the first and only OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms. It has been proven more effective than other intra-nasal hay fever and allergy treatments and offers 24-hour non-drowsy symptom relief[2].

What marketing strategies have contributed to the success of Flonase Allergy Relief?

Effective marketing strategies, such as the "Greatest Season Ever" campaign that leveraged baseball season to remind consumers about allergy season, have significantly boosted sales and engagement for Flonase Allergy Relief[5].

Sources

  1. EMPR: FLONASE ALLERGY RELIEF Prescription & Dosage Information.
  2. GSK: FDA approves Flonase allergy relief for sale over-the-counter in the United States.
  3. Data Bridge Market Research: Nasal Spray Market Size, Share Analysis & Leaders By 2031.
  4. HCPLive: Allergy Year in Review: 2024.
  5. MMA Global: Flonase Greatest Season Ever Case Study.

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