CLINICAL TRIALS PROFILE FOR ASMANEX HFA

All Clinical Trials for ASMANEX HFA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00442117 ↗	A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-06-01	This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.
NCT00461812 ↗	A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma	Terminated	Schering-Plough	Phase 4	2007-04-01	The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.
NCT00461812 ↗	A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma	Terminated	Johns Hopkins University	Phase 4	2007-04-01	The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.
NCT00394355 ↗	Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2006-09-01	This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.
NCT00442351 ↗	Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)	Terminated	Merck Sharp & Dohme Corp.	Phase 4	2006-09-01	This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

Clinical Trial Conditions for ASMANEX HFA

Condition Name

Condition Name for ASMANEX HFA
Intervention	Trials
Asthma	11
Spinal Cord Injury	1

Condition MeSH

Condition MeSH for ASMANEX HFA
Intervention	Trials
Asthma	10
Spinal Cord Injuries	1
Inflammation	1
Wounds and Injuries	1

Clinical Trial Locations for ASMANEX HFA

Trials by Country

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Trials by Country for ASMANEX HFA
Location	Trials
United States	18
United Kingdom	1

Trials by US State

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−

Trials by US State for ASMANEX HFA
Location	Trials
New York	2
Florida	2
Ohio	1
North Carolina	1
Missouri	1

Clinical Trial Progress for ASMANEX HFA

Clinical Trial Phase

Clinical Trial Phase for ASMANEX HFA
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ASMANEX HFA
Clinical Trial Phase	Trials
Completed	8
Terminated	2
Unknown status	1

Clinical Trial Sponsors for ASMANEX HFA

Sponsor Name

Sponsor Name for ASMANEX HFA
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
Schering-Plough	2
Teva Pharmaceuticals USA	1

Sponsor Type

Sponsor Type for ASMANEX HFA
Sponsor	Trials
Industry	11
Other	5
NIH	1

Asmanex HFA: Clinical Trials, Market Analysis, and Projections

Introduction

Asmanex HFA, an inhalation aerosol containing mometasone furoate, is a crucial medication for the maintenance treatment of asthma. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Approvals

Pediatric Approvals

In a significant development, the FDA approved updated labeling for Asmanex HFA to include its use in pediatric patients with asthma. This approval was based on a 12-week, double-blind, placebo-controlled study involving 583 patients aged 5 to less than 12 years with persistent asthma. The study demonstrated that Asmanex HFA 50mcg was statistically superior to placebo in improving AM predose percent predicted FEV1 at the end of the dosing interval[1].

Study Outcomes

The clinical trial showed that patients treated with Asmanex HFA 50mcg had a significant improvement in lung function compared to those receiving a placebo. The safety profile and effectiveness in this age group were consistent with those observed in patients aged 12 years and older[1].

Adverse Reactions

Common adverse reactions reported in clinical trials for Asmanex HFA include nasopharyngitis, headache, sinusitis, bronchitis, and influenza. These reactions are generally mild and manageable, aligning with the safety profile observed in older patients[4][5].

Market Analysis

Current Market

Asmanex HFA is part of the metered dose inhaler (MDI) market, which has seen significant growth in recent years. The MDI market, dominated by hydrofluoroalkane (HFA) propellants, has replaced chlorofluorocarbon (CFC) inhalers due to environmental concerns. In 2020, approximately 1,284 metric tons of HFC-134a and 207 metric tons of HFC-227ea were used in MDIs sold in the United States[2][3].

Market Share

Merck, the manufacturer of Asmanex HFA, is a key player in the MDI market. The company's products, including Asmanex HFA and Dulera, hold a significant share in the asthma treatment segment. The market for MDIs is expected to grow at a rate of about 1% per year through 2025, aligned with population growth and the prevalence of asthma and COPD[2][3].

Market Projections

Growth Rate

The demand for HFA MDIs, including Asmanex HFA, is projected to continue growing. By 2025, the amount of HFC propellant in MDIs sold in the United States is estimated to increase to approximately 1,373 metric tons of HFC-134a and 222 metric tons of HFC-227ea[2][3].

Future Propellants

Research is ongoing to find alternative propellants to HFC-134a and HFC-227ea, such as HFO-1234ze(E) and HFC-152a. However, these alternatives are not expected to replace current HFCs in the near future, ensuring the continued relevance of Asmanex HFA and other HFA MDIs[2][3].

Patient Preferences and Needs

Reliever Medications

Patients often prefer MDIs like Asmanex HFA for their convenience and effectiveness in managing asthma exacerbations. The need for reliever medications that can be administered quickly and efficiently continues to drive the demand for HFA MDIs[2].

Patient Safety and Efficacy

The safety and efficacy of Asmanex HFA have been well-established in clinical trials. Patients and healthcare providers can rely on this medication for long-term asthma management, contributing to its market stability and growth[1][4].

Regulatory Environment

FDA Regulations

The FDA's approval process ensures that medications like Asmanex HFA meet stringent safety and efficacy standards. The recent approval for pediatric use underscores the FDA's commitment to expanding treatment options for younger patients[1].

Environmental Considerations

The shift from CFC to HFA propellants was driven by environmental regulations. While HFCs are currently used, ongoing research into more environmentally friendly alternatives may influence future market trends and regulatory requirements[2][3].

Key Takeaways

• Clinical Trials: Asmanex HFA has been approved for use in pediatric patients based on positive clinical trial outcomes.
• Market Analysis: The MDI market, including Asmanex HFA, is expected to grow at a rate of about 1% per year through 2025.
• Projections: The demand for HFA MDIs is projected to continue, with estimated increases in HFC propellant use.
• Patient Preferences: Patients prefer MDIs for their convenience and effectiveness in managing asthma.
• Regulatory Environment: The FDA continues to regulate and approve medications based on safety and efficacy standards.

FAQs

What is Asmanex HFA used for?

Asmanex HFA is used for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

What were the key findings of the pediatric clinical trials for Asmanex HFA?

The trials showed that Asmanex HFA 50mcg was statistically superior to placebo in improving lung function in pediatric patients with persistent asthma.

What are the common adverse reactions associated with Asmanex HFA?

Common adverse reactions include nasopharyngitis, headache, sinusitis, bronchitis, and influenza.

How is the market for MDIs, including Asmanex HFA, expected to grow?

The market is expected to grow at a rate of about 1% per year through 2025, aligned with population growth and the prevalence of asthma and COPD.

Are there any environmental concerns related to the propellants used in Asmanex HFA?

Yes, there are ongoing efforts to find more environmentally friendly propellants to replace HFCs, but current alternatives are not expected to replace HFCs in the near future.

Sources

1. eMPR.com: Pediatric Approvals Granted to Two Asthma Therapies
2. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry
3. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry (PDF)
4. FDA: Safety Evaluator Division of Pharmacovigilance I - Asmanex HFA
5. FDA: ASMANEX® HFA 100 mcg (mometasone furoate) Inhalation Aerosol Label