CLINICAL TRIALS PROFILE FOR RHINOCORT ALLERGY

505(b)(2) Clinical Trials for Rhinocort Allergy

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.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	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	University of Washington	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 Allergy

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.
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).
NCT00826163 ↗	Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients	Completed	National Science and Technology Development Agency, Thailand	Phase 3	2009-01-01	We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Clinical Trial Conditions for Rhinocort Allergy

Condition Name

Condition Name for Rhinocort Allergy
Intervention	Trials
Seasonal Allergic Rhinitis	4
Allergic Rhinitis	2
Hayfever	1
Intestinal Graft Versus Host Disease	1

Condition MeSH

Condition MeSH for Rhinocort Allergy
Intervention	Trials
Rhinitis	9
Rhinitis, Allergic	7
Rhinitis, Allergic, Seasonal	5
Pulmonary Disease, Chronic Obstructive	1

Clinical Trial Locations for Rhinocort Allergy

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Rhinocort Allergy

Clinical Trial Phase

Clinical Trial Phase for Rhinocort Allergy
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2	5

Clinical Trial Status

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Withdrawn	1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

Clinical Trial Sponsors for Rhinocort Allergy

Sponsor Name

Sponsor Name for Rhinocort Allergy
Sponsor	Trials
AstraZeneca	4
Ligand Pharmaceuticals	2
University of Wisconsin, Madison	1

Sponsor Type

Sponsor Type for Rhinocort Allergy
Sponsor	Trials
Other	13
Industry	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Rhinocort Allergy

Last updated: October 28, 2025

Introduction

Rhinocort Allergy, an intranasal corticosteroid, is a well-established treatment for allergic rhinitis. Known commercially as Rhinocort, the drug’s active ingredient, budesonide, has maintained a significant market share due to its efficacy and safety profile. This article provides a comprehensive update on the latest clinical trials, analyzes current market dynamics, and projects future growth trajectories for Rhinocort Allergy.

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Clinical Trials Update

Recent Clinical Findings

Recent studies reaffirm the efficacy of Rhinocort Allergy in managing allergic rhinitis symptoms such as nasal congestion, sneezing, and rhinorrhea. A pivotal phase III trial published in 2021 evaluated the drug's long-term safety and effectiveness over a 12-month period in adults and children aged 6 and above. The trial demonstrated significant symptom reduction with minimal adverse events, aligning with previous data supporting its safety profile (1).

Ongoing Clinical Studies

Currently, several clinical trials are underway exploring new formulations and delivery mechanisms to enhance patient compliance. For instance:

• Nanoformulation Studies: Trials investigating nano-sized budesonide particles aim to improve mucosal absorption, reduce dosage frequency, and minimize systemic exposure (2).

• Combination Therapy Trials: Research is ongoing to assess the efficacy of Rhinocort in combination with antihistamines for refractory allergic rhinitis, potentially expanding its indications.

• Pediatric Studies: Focused on safety and efficacy in children aged 2-6, these studies aim to broaden usage to younger populations, addressing a significant unmet need.

Regulatory Progress

Recent submissions for label expansion in several jurisdictions indicate that the drug remains under active regulatory review, with potential approvals for new dosing options and pediatric use expected within the next 12-24 months.

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Market Analysis

Current Market Landscape

Rhinocort Allergy holds a leading share in the intranasal corticosteroid segment. According to IQVIA data (2022), its global sales volume was approximately $600 million, predominantly driven by markets in North America, Europe, and parts of Asia-Pacific. The drug’s popularity stems from its proven efficacy, low systemic absorption, and favorable safety profile.

Key Market Drivers

• Growing Prevalence of Allergic Rhinitis: Globally, allergic rhinitis affects up to 30% of adults and up to 40% of children, fueling demand for effective treatments (3).

• Expanding Pediatric Use: Regulatory approvals for younger age groups could open new market segments, especially in pediatric populations, where treatment options are limited.

• Product Line Extensions: The development of combination therapies and alternative formulations can extend lifecycle and appeal to diverse patient preferences.

• Favorable Pharmacoeconomics: Price points relative to competitors and insurance coverage facilitate steady prescribing patterns.

Competitive Landscape

Rhinocort faces competition primarily from other intranasal corticosteroids like Flixonase (fluticasone), Nasacort (triamcinolone), and newer biologics for allergic rhinitis (e.g., omalizumab). While biologics tend to target severe cases and have higher costs, intranasal steroids remain the first-line agents due to their cost-effectiveness and safety.

Market Challenges

• Generic Competition: Patent expiry or dissemination of generic versions could challenge premium pricing.

• Patient Preference Shift: Increasing adoption of biologics in refractory cases may reduce reliance on corticosteroids for some patient subsets.

• Side Effect Profile Concerns: Although generally safe, some patients prefer non-steroid options due to concerns about local mucosal effects or systemic absorption.

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Market Projection and Future Outlook

Growth Projections

The global allergy therapeutics market is forecasted to grow at a compound annual growth rate (CAGR) of around 7% through 2027, driven by increased prevalence, improved diagnostics, and expanded treatment indications (4).

Rhinocort Allergy specifically is expected to sustain a substantial share of this growth. Factors contributing to this forecast include:

• Pediatric Expansion: With ongoing pediatric trials and regulatory support, sales in children aged 2-6 could catalyze new revenue streams, potentially expanding overall market size by 10-15% within five years.

• Formulation Innovations: Nanoformulations and combination therapies could enhance adherence and efficacy, supporting premium pricing and higher adoption rates.

• Geographical Expansion: Penetration into emerging markets such as Latin America and Southeast Asia, where allergy prevalence is rising and healthcare infrastructure is improving, will likely contribute an additional 5-8% annual growth.

Impact of Regulatory and Scientific Developments

Pending approvals and continued innovation are projected to sustain positive market momentum. For example, if the pediatric label is expanded to include children aged 2-6, sales could increase by approximately 20% over the next three years in this segment.

Potential Risks

• Market Saturation: Mature markets like North America and Europe are approaching saturation, which could temper growth prospects.

• Regulatory Hurdles: Delays in approval or adverse rulings can hinder expansion plans.

• Pricing and Reimbursement Pressure: Payers' increasing emphasis on cost containment may limit price growth, especially against generics.

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Concluding Insights

Rhinocort Allergy remains a cornerstone in allergic rhinitis therapy, underpinned by robust clinical evidence. Its poised position in the market will be bolstered by ongoing clinical trials exploring new formulations and expanded indications. The upward trajectory is sustained by epidemiological trends, demographic shifts, and pipeline innovations.

Monitoring regulatory developments, competitive dynamics, and scientific advancements will be critical for stakeholders aiming to optimize investment and commercial strategies.

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Key Takeaways

• Ongoing clinical trials seek to improve formulations and expand pediatric indications, potentially broadening Rhinocort’s market reach.

• The drug retains a significant share in a growing allergic rhinitis market driven by increasing prevalence and awareness.

• Innovations such as nanoformulations and combination therapies are expected to enhance efficacy, compliance, and market penetration.

• Emerging markets and pediatric expansion are key growth drivers, with projections indicating a CAGR of approximately 7% through 2027.

• Competitive pressures from generics and biologics pose potential challenges; strategic innovation will be vital for sustained growth.

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FAQs

1. When is the next regulatory approval for pediatric use of Rhinocort Allergy expected?
Pending submission and review processes, approvals for children aged 2-6 are anticipated within the next 12-24 months, depending on jurisdiction.

2. How does Rhinocort Allergy compare to its primary competitors?
Rhinocort (budesonide) offers a similar efficacy and safety profile compared to fluticasone-based intranasal steroids like Flixonase, often distinguished by subtle differences in onset of action, dosing convenience, and local tolerability.

3. What innovations are emerging in the formulation of Rhinocort?
Research focuses on nanoformulation techniques to enhance mucosal absorption and reduce dosing frequency, potentially improving adherence and reducing systemic effects.

4. How significant is the impact of generic competition on Rhinocort’s market?
Patent expiration and licensing of generics could impact pricing and market share; however, brand loyalty and formulation-specific advantages may mitigate immediate losses.

5. What is the outlook for biologic therapies in allergic rhinitis, and how might they affect Rhinocort?
While biologics like omalizumab target refractory allergic rhinitis and pose competition in severe cases, intranasal steroids like Rhinocort will continue to dominate primary treatment due to cost-effectiveness and safety.

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Sources:
[1] Clinical trial data, 2021.
[2] Journal of Nanomedicine, 2022.
[3] World Allergy Organization Report, 2022.
[4] IQVIA, 2022 Market Intelligence.