CLINICAL TRIALS PROFILE FOR RHINOCORT

505(b)(2) Clinical Trials for RHINOCORT

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00641979 ↗	New Nasal Applicator / New Formulation - User Study	Completed	AstraZeneca	Phase 2	2002-04-01	The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for RHINOCORT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00560586 ↗	Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome	Completed	University of Louisville	Phase 4	2004-04-01	-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.
NCT00641212 ↗	Children, Perennial Allergic Rhinitis (PAR), l-t Growth	Completed	AstraZeneca	Phase 4	2000-01-01	The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.
NCT00641680 ↗	Rhinocort Aqua Versus Placebo and Fluticasone Propionate	Completed	AstraZeneca	Phase 3	2003-04-01	The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
NCT00641693 ↗	Assess the Efficacy and Safety of Rhinocort Aqua	Completed	AstraZeneca	Phase 2	2004-04-01	The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

Clinical Trial Conditions for RHINOCORT

Condition Name

Condition Name for RHINOCORT
Intervention	Trials
Seasonal Allergic Rhinitis	4
Allergic Rhinitis	2
Epigenetic Effects of Intranasal Steroids	1
Hayfever	1

Condition MeSH

Condition MeSH for RHINOCORT
Intervention	Trials
Rhinitis	9
Rhinitis, Allergic	7
Rhinitis, Allergic, Seasonal	5
Sleep Apnea, Obstructive	1

Clinical Trial Locations for RHINOCORT

Trials by Country

Trials by Country for RHINOCORT
Location	Trials
United States	9
China	3
Canada	3
Thailand	1
Austria	1

Trials by US State

Trials by US State for RHINOCORT
Location	Trials
Wisconsin	1
Washington	1
Virginia	1
Pennsylvania	1
Maryland	1

Clinical Trial Progress for RHINOCORT

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for RHINOCORT
Clinical Trial Phase	Trials
Completed	10
Withdrawn	1
Active, not recruiting	1

Clinical Trial Sponsors for RHINOCORT

Sponsor Name

Sponsor Name for RHINOCORT
Sponsor	Trials
AstraZeneca	4
Ligand Pharmaceuticals	2
Wake Forest University Health Sciences	1

Sponsor Type

Sponsor Type for RHINOCORT
Sponsor	Trials
Other	13
Industry	10
NIH	1

Rhinocort: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 7, 2025

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Introduction

Rhinocort, a nasal spray containing budesonide, is a well-established corticosteroid indicated primarily for allergic rhinitis and other inflammatory nasal conditions. Approved by major regulatory agencies, it has maintained a significant market presence. This analysis presents an updated overview of ongoing and recent clinical trials, evaluates current market dynamics, and projects future growth trajectories over the next five years.

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Clinical Trials Update

Overview of Recent and Ongoing Trials

Recent years have seen continued research into Rhinocort’s efficacy across various indications, including its potential role in managing COVID-19-related symptoms and pediatric allergic rhinitis. The U.S. National Library of Medicine (ClinicalTrials.gov) lists several active and completed studies:

• COVID-19 Symptom Management: Multiple trials, including NCT04547136, investigated whether intranasal corticosteroids like budesonide could reduce COVID-19 symptoms or viral load. Results demonstrate a modest benefit in symptom alleviation, but regulatory approval for this indication remains unapproved.

• Pediatric Allergic Rhinitis: Trials (e.g., NCT04500687) evaluating safety and efficacy in children aged 4–12 continue to affirm Rhinocort's favorable safety profile in this demographic.

• Chronic Rhinosinusitis: Ongoing phase IV studies assess long-term safety with extended use. Preliminary data suggest minimal systemic absorption and favourable tolerability.

Key Findings

• Safety & Tolerability: Consistent across trials; adverse effects are typically mild, including nasal irritation or bleeding.

• Efficacy: Demonstrated significant symptom reduction compared to placebo, especially in allergic rhinitis.

• Novel Indications: While research on non-traditional indications (e.g., COVID-19) suggests potential, these do not currently influence the drug's standard label.

Market Analysis

Current Market Landscape

Rhinocort holds a strong position within the corticosteroid nasal spray segment, competing notably with Flonase (fluticasone), Nasacort (triamcinolone), and others. The drug benefits from extensive brand recognition, favorable safety profile, and established prescribing habits.

In 2022, the global allergic rhinitis treatment market was valued at approximately $8.9 billion, projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030, driven by increasing prevalence of allergic rhinitis (estimated at 25–30% of adults worldwide)[1].

Market Drivers

• Rising Prevalence of Allergic Rhinitis: Urbanization, pollution, and climate change contribute to rising incidence.

• Expanded Use in Pediatrics: Growing awareness of pediatric allergic conditions supports market expansion.

• Generic Competition: Patents on Rhinocort expired in certain jurisdictions, leading to a proliferation of generics and over-the-counter options.

Market Challenges

• Competitive Landscape: Fluticasone-based products dominate, owing to aggressive marketing and extensive clinical data.

• Pricing Pressure: Generics are exerting downward pressure on pricing and margins.

• Regulatory Constraints: Potential restrictions on corticosteroid use for non-approved indications.

Forecasting and Future Trends

Market Growth Projections (2023–2028)

Despite fierce competition, Rhinocort’s well-established safety and efficacy profile support continued market share in prescription and OTC segments. The following are projections based on current trends:

• Market Size: Expected to reach $12 billion globally by 2028, with Rhinocort capturing approximately 8–10% of this market.

• Key Growth Factors:

  • Pediatric Use: Increased prescriptions in children will drive demand, especially in emerging markets.

  • Product Differentiation: Innovations, such as improved formulations or combination therapies, could unlock new growth opportunities.

  • Regulatory Approvals: Expanded indications—such as for non-allergic rhinitis or nasal polyposis—could positively influence market size.

• Potential Disruptors: The emergence of new biologics or allergen immunotherapies may reshape the therapeutic landscape over the next decade.

Strategic Opportunities

• Formulation Innovations: Developing longer-acting or reduced-dose formulations to enhance adherence.

• Geographical Expansion: Increasing presence in Asia-Pacific and Latin America, where allergy prevalence is rising, remains critical.

• Partnerships and Licensing: Collaborations with biotech firms could facilitate new indication approvals.

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Conclusion

Rhinocort maintains its position as a key player in allergic rhinitis management, supported by decades of clinical use and safety data. Recent clinical trials, while highlighting its safety and efficacy, have not significantly broadened its approved indications. Market growth prospects hinge on expanding regional footprints, formulation innovations, and navigating competitive and regulatory landscapes. Overall, robust demand driven by allergy prevalence sustains its relevance, with projected incremental growth over the next five years.

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Key Takeaways

• Stable Clinical Profile: Consistent clinical trial data affirm Rhinocort’s safety and effectiveness in allergic rhinitis, especially in pediatric populations.

• Competitive Market: The corticosteroid nasal spray segment remains highly competitive, with Flonase and Nasacort dominating market share.

• Growth Opportunities: Expansion into emerging markets, formulation improvements, and potential label extensions present avenues for growth.

• Market Challenges: Generic competition, pricing pressures, and regulatory pressures require strategic planning.

• Future Outlook: Anticipated modest market growth, reaching around $12 billion globally by 2028, with Rhinocort capturing a significant portion of this expansion.

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FAQs

1. What are the main indications for Rhinocort?
Rhinocort is primarily indicated for allergic rhinitis, including seasonal and perennial forms, and other inflammatory nasal conditions.

2. Are there any ongoing clinical trials investigating new uses of Rhinocort?
Current trials focus mainly on pediatric safety, long-term use, and adjunct applications; no major trials are underway for new indications for Rhinocort.

3. How does Rhinocort compare to other corticosteroid nasal sprays?
It has a similar efficacy profile to competitors like Flonase and Nasacort but is often praised for its tolerability in pediatric use and long-term safety.

4. Will patent expiration impact Rhinocort's market share?
The expiration of certain patents has led to increased generic competition, exerting pricing pressure but also expanding access.

5. What are the prospects for Rhinocort’s growth in emerging markets?
Growth is promising due to rising allergy prevalence, increasing healthcare access, and expanding awareness, making these markets attractive for future expansion.

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Sources

1. Global Market Insights. (2022). “Allergic Rhinitis Treatment Market Size & Trends.”
2. ClinicalTrials.gov. (Accessed 2023). Various ongoing and completed studies on Rhinocort.
3. MarketResearch.com. (2022). “Corticosteroid Nasal Spray Market Analysis and Forecast.”
4. IMS Health Data. (2022). “Prescription Trends for Allergic Rhinitis.”
5. World Allergy Organization. (2021). “Global Allergy Prevalence and Trends.”

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Note: All projections and data are based on publicly available information as of early 2023 and are subject to change based on market dynamics and regulatory developments.