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Last Updated: January 4, 2025

CLINICAL TRIALS PROFILE FOR RHINOCORT ALLERGY


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
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).
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

All Clinical Trials for RHINOCORT ALLERGY

Trial IDTitleStatusSponsorPhaseStart DateSummary
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
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.
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.
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.
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).
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for RHINOCORT ALLERGY

Condition Name

4211000.511.522.533.54Seasonal Allergic RhinitisAllergic RhinitisAcute Graft Versus Host DiseaseRhinitis[disabled in preview]
Condition Name for RHINOCORT ALLERGY
Intervention Trials
Seasonal Allergic Rhinitis 4
Allergic Rhinitis 2
Acute Graft Versus Host Disease 1
Rhinitis 1
[disabled in preview] 0
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Condition MeSH

97500123456789RhinitisRhinitis, AllergicRhinitis, Allergic, SeasonalLung Diseases[disabled in preview]
Condition MeSH for RHINOCORT ALLERGY
Intervention Trials
Rhinitis 9
Rhinitis, Allergic 7
Rhinitis, Allergic, Seasonal 5
Lung Diseases 1
[disabled in preview] 0
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Clinical Trial Locations for RHINOCORT ALLERGY

Trials by Country

+
Trials by Country for RHINOCORT ALLERGY
Location Trials
United States 9
Canada 3
China 3
Austria 1
Thailand 1
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Trials by US State

+
Trials by US State for RHINOCORT ALLERGY
Location Trials
Pennsylvania 1
Maryland 1
District of Columbia 1
California 1
North Carolina 1
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Clinical Trial Progress for RHINOCORT ALLERGY

Clinical Trial Phase

38.5%23.1%38.5%0-0.500.511.522.533.544.555.5Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for RHINOCORT ALLERGY
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2 5
[disabled in preview] 0
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Clinical Trial Status

76.9%7.7%7.7%7.7%012345678910CompletedActive, not recruitingRecruiting[disabled in preview]
Clinical Trial Status for RHINOCORT ALLERGY
Clinical Trial Phase Trials
Completed 10
Active, not recruiting 1
Recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for RHINOCORT ALLERGY

Sponsor Name

trials011223344AstraZenecaLigand PharmaceuticalsDaniel Merenstein[disabled in preview]
Sponsor Name for RHINOCORT ALLERGY
Sponsor Trials
AstraZeneca 4
Ligand Pharmaceuticals 2
Daniel Merenstein 1
[disabled in preview] 3
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Sponsor Type

54.2%41.7%002468101214OtherIndustryNIH[disabled in preview]
Sponsor Type for RHINOCORT ALLERGY
Sponsor Trials
Other 13
Industry 10
NIH 1
[disabled in preview] 0
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RHINOCORT ALLERGY Market Analysis and Financial Projection

Rhinocort Allergy: Clinical Trials, Market Analysis, and Projections

Introduction to Rhinocort Allergy

Rhinocort Allergy, commonly known by its active ingredient budesonide, is a widely used intranasal corticosteroid for the treatment of allergic rhinitis. This medication is effective in reducing inflammation and alleviating symptoms such as congestion, sneezing, and runny nose.

Clinical Trials Update

Current and Recent Trials

One notable clinical trial involving Rhinocort Aqua (budesonide) is the double-blind, double-dummy, randomized, placebo-controlled, cross-over exploratory study conducted by AstraZeneca. This study aims to assess the efficacy of Rhinocort Aqua in combination with intranasal Oxis Turbuhaler in an allergic rhinitis challenge model. The trial is designed to evaluate the therapeutic effects of this combination in patients with allergic rhinitis[1].

Another significant trial compares the novel water-soluble budesonide nasal spray (Budesolv) with the marketed Rhinocort® aqua 64. The primary objective of this trial is to demonstrate therapeutic equivalence/non-inferiority and the early onset of action of Budesolv in patients suffering from grass pollen-induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. The results indicate that Budesolv is therapeutically equivalent to Rhinocort® aqua 64, highlighting the potential of new formulations in the treatment of allergic rhinitis[4].

Market Analysis

Current Market Trends

The allergic rhinitis market, which includes Rhinocort Allergy, has seen significant dynamics in recent years. According to Datamonitor, the allergic rhinitis market in the seven major markets was valued at $5 billion in 2009 but was forecasted to decline to $4.2 billion by 2019 due to the impact of generics. However, nasal corticosteroids like Rhinocort Allergy are partially protected by their device, making them less vulnerable to generic erosion compared to oral antihistamines[2].

Growth Projections

Despite the decline in some segments, the overall allergic rhinitis drugs market is expected to grow. Technavio reports that the global allergic rhinitis drugs market is poised to grow by USD 2.25 billion during 2019-2023, progressing at a CAGR of close to 4% during the forecast period. This growth is driven by increasing awareness about allergic rhinitis and the rising demand for over-the-counter medicines[5].

Role of Immunotherapy

Immunotherapy is emerging as a significant segment within the allergic rhinitis market. Changing regulations are driving the development of immunotherapies, and large-scale development programs have been observed in recent years. While immunotherapy is expected to remain a niche market, it is forecasted to see significant growth. For example, sublingual grass tablets like Grazax and Oralair are expected to have substantial sales in the US and EU by 2019[2].

Market Drivers and Challenges

Drivers

  • Increasing Awareness: Growing awareness about allergic rhinitis is driving the demand for treatments, including Rhinocort Allergy.
  • Over-the-Counter Demand: The increasing demand for over-the-counter medicines is boosting the growth of the allergic rhinitis drugs market[5].

Challenges

  • Generic Erosion: The entry of cheap generics, particularly in the US, poses a significant threat to the market. However, nasal corticosteroids like Rhinocort Allergy are somewhat protected due to their device-based delivery[2].
  • Regulatory Changes: Changing regulations can impact the development and approval of new therapies, but they also drive innovation in areas like immunotherapy.

Key Companies and Pipeline Products

Several companies are actively involved in the development of new therapies for allergic rhinitis. Key players include Regeneron, Revolo Biotherapeutics, Inmunotek, NeuCen BioMed, and others. These companies are working on novel therapies, including immunotherapies, which are expected to drive the market in the upcoming years[3].

Epidemiology and Patient Pool

The allergic rhinitis market is influenced by the epidemiology of the condition. DelveInsight's report provides an in-depth understanding of the historical and forecasted epidemiology of allergic rhinitis in the US, EU5, and Japan. The increasing patient pool and growing need for effective treatments are key factors driving the market[3].

Conclusion

Rhinocort Allergy remains a significant player in the allergic rhinitis market, supported by ongoing clinical trials and a favorable market landscape. Despite challenges from generic erosion, the market is expected to grow driven by increasing awareness and the demand for over-the-counter medicines. The emergence of immunotherapies and new formulations further underscores the potential for growth in this segment.

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the efficacy of Rhinocort Aqua in combination with other treatments and comparing new formulations like Budesolv.
  • Market Growth: The global allergic rhinitis drugs market is expected to grow by USD 2.25 billion during 2019-2023.
  • Immunotherapy: This segment is seeing significant growth and innovation driven by changing regulations.
  • Market Drivers: Increasing awareness and demand for over-the-counter medicines are key drivers.
  • Challenges: Generic erosion remains a threat, but nasal corticosteroids are somewhat protected.

FAQs

Q: What is the primary objective of the clinical trial involving Rhinocort Aqua and Oxis Turbuhaler? A: The primary objective is to assess the efficacy of Rhinocort Aqua in combination with intranasal Oxis Turbuhaler in an allergic rhinitis challenge model[1].

Q: How does the market for allergic rhinitis drugs forecast to grow? A: The global allergic rhinitis drugs market is poised to grow by USD 2.25 billion during 2019-2023, progressing at a CAGR of close to 4%[5].

Q: What is the impact of generics on the allergic rhinitis market? A: Generics, particularly in the US, pose a significant threat, but nasal corticosteroids like Rhinocort Allergy are partially protected by their device-based delivery[2].

Q: Which companies are actively involved in the development of new therapies for allergic rhinitis? A: Key companies include Regeneron, Revolo Biotherapeutics, Inmunotek, NeuCen BioMed, and others[3].

Q: What role does immunotherapy play in the allergic rhinitis market? A: Immunotherapy is expected to remain a niche market but is forecasted to see significant growth driven by changing regulations and large-scale development programs[2].

Sources

  1. AstraZeneca Clinical Trials: "A double-blind, double-dummy, randomized, placebo-controlled, cross-over exploratory study to assess the efficacy of Rhinocort Aqua (budesonide) nasal spray in combination with intranasal Oxis Turbuhaler in an allergic Rhinitis challenge model."
  2. Reportlinker: "Reportlinker Adds Pipeline and Commercial Insight: Allergic Rhinitis."
  3. EIN Presswire: "Allergic Rhinitis Market Forecast 2032: FDA Approvals, Clinical Trials, Drugs, Epidemiology & Companies by DelveInsight."
  4. Clinical Trials Register: "EudraCT Number 2018-001324-19 - Clinical trial results."
  5. Business Wire: "Global Allergic Rhinitis Drugs Market 2019-2023 - Evolving Opportunities with ALK-Abelló, GlaxoSmithKline, Technavio."

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