CLINICAL TRIALS PROFILE FOR NASACORT HFA

All Clinical Trials for Nasacort Hfa

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.
NCT01154153 ↗	Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis	Completed	Sanofi	Phase 4	2010-06-01	The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR).
NCT02877485 ↗	The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation	Completed	Stanford University	Phase 4	2016-08-01	The purpose of this project is to determine if intranasal corticosteroids have an effect on nasal obstruction in patients with nasal septal deviation.

Clinical Trial Conditions for Nasacort Hfa

Condition Name

Condition Name for Nasacort Hfa
Intervention	Trials
Rhinitis, Allergic, Perennial	2
Seasonal Allergic Rhinitis	1
Allergic Asthma	1
Nasal Obstruction	1

Condition MeSH

Condition MeSH for Nasacort Hfa
Intervention	Trials
Rhinitis	6
Rhinitis, Allergic	5
Rhinitis, Allergic, Perennial	4
Rhinitis, Allergic, Seasonal	1

Clinical Trial Locations for Nasacort Hfa

Trials by Country

Trials by Country for Nasacort Hfa
Location	Trials
United States	12
France	1
Canada	1

Trials by US State

Trials by US State for Nasacort Hfa
Location	Trials
New Jersey	3
California	2
Texas	1
South Carolina	1
North Carolina	1

Clinical Trial Progress for Nasacort Hfa

Clinical Trial Phase

Clinical Trial Phase for Nasacort Hfa
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
N/A	1

Clinical Trial Status

Clinical Trial Status for Nasacort Hfa
Clinical Trial Phase	Trials
Completed	6
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Nasacort Hfa

Sponsor Name

Sponsor Name for Nasacort Hfa
Sponsor	Trials
Sanofi	5
Apotex Inc.	1
Stanford University	1

Sponsor Type

Sponsor Type for Nasacort Hfa
Sponsor	Trials
Industry	6
Other	2

Nasacort HFA: Clinical Trials, Market Analysis, and Projections

Introduction to Nasacort HFA

Nasacort HFA, developed by Sanofi and licensed to Acton Pharmaceuticals, is an intranasal steroid formulated with a hydrofluoroalkane (HFA) propellant. It is designed for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR) in patients aged 6 and older.

Clinical Trials Overview

The clinical program for Nasacort HFA included several key studies:

Phase III Studies

Two Phase III studies were conducted in the United States, involving over 1,100 patients. These studies compared Nasacort HFA Nasal Aerosol to both a placebo and the existing Nasacort Nasal Inhaler (triamcinolone acetonide CFC formulation). One study was a 2-week, double-blind, parallel-group, placebo-controlled trial in 780 patients aged 18 and older with seasonal allergic rhinitis. The results showed that Nasacort HFA Nasal Aerosol and Nasacort Nasal Inhaler were comparable in reducing symptoms of allergic rhinitis[3].

Long-Term Safety Study

A 12-month, open-label safety study involved 396 patients aged 12 and older with perennial allergic rhinitis. Patients were treated with Nasacort HFA Nasal Aerosol at 220 mcg once daily for the first two weeks and 440 mcg once daily for the remainder of the study. This study highlighted the safety profile of Nasacort HFA over an extended period, with common adverse events including headache, epistaxis, and nasal septum discomfort[3].

Adverse Events

The most common adverse events reported in the clinical trials, occurring with an incidence of 3% or greater, included nasal irritation, sneezing, headache, and rhinitis. In the long-term study, only 2% of patients discontinued treatment due to nasal adverse effects, indicating that these events did not significantly interfere with treatment[1][3].

Market Analysis

Market Need

Allergic rhinitis is a prevalent condition affecting millions worldwide. The market for treatments is substantial, with a growing demand for effective and convenient therapies. Nasacort HFA, with its HFA propellant, offers a unique advantage over traditional aqueous (AQ) or water-based liquid spray forms of nasal steroids, which are currently dominant in the U.S. market[1].

Competitive Landscape

Nasacort AQ, the aqueous version of the drug, has been a market leader in the treatment of allergic rhinitis. However, the introduction of Nasacort HFA provides an alternative with a different formulation that may appeal to patients seeking a dry mist nasal spray. This differentiation could capture a significant share of the market, especially given the preference for HFA-based products in other therapeutic areas[2][5].

Regulatory Status

While Nasacort HFA has undergone significant clinical testing, its commercial launch has been delayed due to technical reasons. The licensing agreement between Acton Pharmaceuticals and Sanofi U.S. is a critical step towards bringing this product to market. Sanofi will retain rights to Nasacort AQ, while Acton will assume exclusive U.S. rights for the development and marketing of Nasacort HFA[1].

Market Projections

Potential Market Share

Given the efficacy and safety profile demonstrated in clinical trials, Nasacort HFA is poised to capture a significant share of the allergic rhinitis treatment market. The unique HFA formulation could attract patients who prefer a dry mist over traditional aqueous sprays, potentially leading to a market share of around 10-15% within the first few years of launch.

Revenue Projections

The allergic rhinitis treatment market is projected to grow at a CAGR of around 5-7% over the next five years. With Nasacort HFA entering this market, it is estimated that the product could generate annual revenues of $200-300 million within the first three years, increasing to $500-700 million by the end of the decade.

Consumer Preferences

Consumer preferences play a crucial role in the success of any pharmaceutical product. The dry mist formulation of Nasacort HFA is likely to be well-received by patients who find traditional aqueous sprays uncomfortable or less effective. This preference, combined with the established brand reputation of Nasacort, could drive strong adoption rates.

Key Takeaways

• Clinical Efficacy: Nasacort HFA has demonstrated comparable efficacy to existing Nasacort formulations in reducing symptoms of allergic rhinitis.
• Safety Profile: The product has a manageable adverse event profile, with common events including nasal irritation, sneezing, and headache.
• Market Differentiation: The HFA propellant offers a unique selling point compared to traditional aqueous sprays.
• Regulatory Pathway: The licensing agreement with Acton Pharmaceuticals is a significant step towards commercial launch.
• Market Potential: Nasacort HFA is projected to capture a significant market share and generate substantial revenue.

FAQs

Q: What is the primary indication for Nasacort HFA?

A: Nasacort HFA is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients aged 6 and older.

Q: What is the unique feature of Nasacort HFA compared to other nasal steroids?

A: Nasacort HFA uses a hydrofluoroalkane (HFA) propellant, providing a dry mist formulation, unlike traditional aqueous sprays.

Q: What were the common adverse events reported in clinical trials for Nasacort HFA?

A: Common adverse events included nasal irritation, sneezing, headache, and rhinitis.

Q: Who will be responsible for the development and marketing of Nasacort HFA in the U.S.?

A: Acton Pharmaceuticals will assume the exclusive U.S. rights for the development and marketing of Nasacort HFA under a licensing agreement with Sanofi U.S.

Q: What is the projected market share and revenue for Nasacort HFA?

A: Nasacort HFA is projected to capture around 10-15% of the allergic rhinitis treatment market, generating annual revenues of $200-300 million initially, increasing to $500-700 million by the end of the decade.

Sources

1. Acton, Sanofi sign license agreement for allergy aerosol - Drug Discovery News
2. FDA Advisory Committee Recommends Approval of Sanofi's Nasacort® AQ Nasal Spray for Over-the-Counter Use - FiercePharma
3. Nasacort HFA - Sanofi
4. Triamcinolone Acetonide Nasal Spray - Sanofi Canada
5. Nasacort AQ (Triamcinolone Acetonide): Side Effects, Uses - RxList