You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 25, 2025

CLINICAL TRIALS PROFILE FOR NASACORT


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Nasacort

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00132925 ↗ An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis Completed Sanofi Phase 3 2003-11-01 The purposes of this study are: - To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial allergic rhinitis; and - To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
NCT00344942 ↗ Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults Terminated Sanofi Phase 3 2006-04-01 To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis
NCT00449072 ↗ Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR) Completed Sanofi Phase 4 2007-03-01 The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months. The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo: - the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal [HPA] axis function) - the rate of treatment-emergent-adverse-events (TEAE) - global efficacy rated by the investigator and the participant separately - the rate of use of rescue medication during the study
NCT00987233 ↗ A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis Completed Apotex Inc. Phase 3 1969-12-31 A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of seasonal allergic rhinitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nasacort

Condition Name

Condition Name for Nasacort
Intervention Trials
Rhinitis, Allergic, Perennial 2
Allergic Asthma 1
Nasal Obstruction 1
Rhinitis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Nasacort
Intervention Trials
Rhinitis 6
Rhinitis, Allergic 5
Rhinitis, Allergic, Perennial 4
Nasal Obstruction 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Nasacort

Trials by Country

Trials by Country for Nasacort
Location Trials
United States 12
Canada 1
France 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Nasacort
Location Trials
New Jersey 3
California 2
Texas 1
South Carolina 1
North Carolina 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Nasacort

Clinical Trial Phase

Clinical Trial Phase for Nasacort
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
N/A 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Nasacort
Clinical Trial Phase Trials
Completed 6
Terminated 1
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Nasacort

Sponsor Name

Sponsor Name for Nasacort
Sponsor Trials
Sanofi 5
Gail Gauvreau 1
Apotex Inc. 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Nasacort
Sponsor Trials
Industry 6
Other 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Nasacort: Clinical Trials, Market Analysis, and Projections

Introduction to Nasacort

Nasacort, also known as triamcinolone acetonide nasal spray, is a widely used medication for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Adult and Adolescent Studies

Numerous clinical trials have demonstrated the efficacy and safety of Nasacort in adults and adolescents. These trials, which include double-blind, placebo-controlled studies, have shown significant relief from symptoms such as sneezing, itching, runny nose, and congestion. For instance, fixed total daily doses of 110, 220, and 440 mcg per day of Nasacort aerosolized triamcinolone acetonide resulted in statistically significant improvements over placebo in treating seasonal and perennial allergic rhinitis[4].

Pediatric Studies

The FDA approved Nasacort AQ for children aged 2-5 years based on a multicenter, randomized, double-blind, placebo-controlled study. This study showed that Nasacort AQ significantly improved the combined symptoms of sneezing, itching, runny nose, and congestion in children with year-round allergic rhinitis. The treatment involved one spray per nostril once daily for four weeks, and the results indicated a greater reduction in Total Nasal Symptom Score (TNSS) compared to the placebo group[2].

Safety Profile

Clinical trials have also highlighted the safety profile of Nasacort. The most common treatment-emergent adverse events (TEAEs) observed were cough, pyrexia, and headache, but these rates were comparable to those in the placebo group. No serious side effects were reported, and the discontinuation rate due to adverse experiences was low, at approximately 1.6%[2][4].

Market Analysis

Global Nasal Spray Market

The global nasal spray market, which includes products like Nasacort, was valued at $25.30 billion in 2022 and is projected to grow to $49.54 billion by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 8.8% during the forecast period. This growth is driven by rising infections and allergic conditions, as well as the advantages of nasal sprays such as efficient and painless drug delivery and better patient convenience[5].

Segmental Growth

The nasal allergies segment dominated the market in 2022, driven by an increasing patient pool suffering from allergies. The asthma segment is also expected to grow rapidly due to the increasing incidence of respiratory diseases and the demand for cost-effective treatment options. The adult segment currently dominates the market due to a higher patient volume, but the pediatric segment is also significant, especially with the approval of Nasacort for children aged 2-5 years[5].

Regional Market

North America held the largest market share in 2022, valued at $11.16 billion. Europe was the second-largest market, driven by the higher adoption of nasal spray products for common cold and allergy treatments. The Asia Pacific region is expected to be the fastest-growing market, driven by strategic partnerships and improving healthcare infrastructure[5].

Market Projections

Growth Drivers

The market for Nasacort and similar nasal sprays is expected to be driven by several factors:

  • Increasing Prevalence of Allergies: The rising number of patients suffering from allergies will continue to drive the demand for nasal sprays.
  • New Product Launches: Pharmaceutical and biotechnology companies are investing heavily in research and development to introduce new products, which will further boost market growth.
  • Patient Convenience: The ease of use and painless delivery of nasal sprays make them a preferred option for many patients[5].

Challenges and Opportunities

Despite the positive outlook, the market faced challenges during the COVID-19 pandemic, which disrupted the supply chain and reduced sales due to a weaker cold and flu season. However, as the pandemic subsides, the market is expected to recover and grow. Strategic partnerships, especially in regions like the Asia Pacific, will play a crucial role in expanding the market[5].

Regulatory Approvals and Over-the-Counter Use

Nasacort AQ has received significant regulatory approvals. In 2013, the FDA's Nonprescription Drugs Advisory Committee recommended approval for over-the-counter use of Nasacort AQ, based on data from 13 placebo-controlled efficacy studies and 43 clinical studies, along with 16 years of post-marketing surveillance data[3].

Key Takeaways

  • Clinical Efficacy: Nasacort has been proven effective in treating nasal symptoms of seasonal and perennial allergic rhinitis in both adults and children.
  • Safety Profile: The drug has a favorable safety profile with minimal serious adverse events.
  • Market Growth: The global nasal spray market is projected to grow significantly, driven by increasing allergic conditions and patient convenience.
  • Regional Dominance: North America currently dominates the market, but the Asia Pacific region is expected to grow rapidly.
  • Regulatory Approvals: Nasacort AQ has been approved for over-the-counter use, expanding its accessibility.

FAQs

What is Nasacort used for?

Nasacort is used for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

Is Nasacort safe for children?

Yes, Nasacort AQ has been approved by the FDA for use in children aged 2-5 years for the treatment of nasal symptoms of year-around allergies.

What are the common side effects of Nasacort?

Common side effects include cough, pyrexia, and headache, but these are generally comparable to those in the placebo group.

How does Nasacort compare to other nasal sprays?

Nasacort has been compared to other nasal sprays like beclomethasone dipropionate and budesonide in clinical trials, showing its efficacy and safety profile.

What is the projected growth of the nasal spray market?

The global nasal spray market is projected to grow from $27.47 billion in 2023 to $49.54 billion by 2030, with a CAGR of 8.8%.

Sources

  1. Medsafe: "agen31-Nasacort.pdf" - Medsafe.
  2. Sanofi: "FDA Approves Nasacort AQ® Nasal Spray for Children Aged 2-5" - Sanofi.
  3. FiercePharma: "FDA Advisory Committee Recommends Approval of Sanofi's Nasacort® AQ Nasal Spray for Over-the-Counter Use" - FiercePharma.
  4. Drugs.com: "Nasacort: Package Insert / Prescribing Information" - Drugs.com.
  5. Fortune Business Insights: "Nasal Spray Market Size, Growth | Trends Analysis [2030]" - Fortune Business Insights.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.