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CLINICAL TRIALS PROFILE FOR XOPENEX HFA

All Clinical Trials for xopenex hfa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124176 ↗	Continuous Levalbuterol for Treatment of Status Asthmaticus in Children	Completed	Sunovion	Phase 4	2004-04-01	This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00124176 ↗	Continuous Levalbuterol for Treatment of Status Asthmaticus in Children	Completed	Children's Hospital of Philadelphia	Phase 4	2004-04-01	This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00500578 ↗	Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	Completed	ICN Pharmaceuticals	Phase 4	2003-02-01	Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
NCT00500578 ↗	Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	Completed	M.D. Anderson Cancer Center	Phase 4	2003-02-01	Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
NCT00583947 ↗	A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects	Completed	Sunovion	Phase 2	2008-01-01	To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
NCT00585039 ↗	Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)	Completed	Phoenix Children's Hospital	Phase 4	2005-09-01	The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.

Clinical Trial Conditions for xopenex hfa

Condition Name

Condition Name for xopenex hfa
Intervention	Trials
Asthma	3
Shock	1
Acute Asthma	1
COPD	1

Condition MeSH

Condition MeSH for xopenex hfa
Intervention	Trials
Asthma	3
Respiratory Tract Infections	1
Neoplasms	1
Hematologic Neoplasms	1

Clinical Trial Locations for xopenex hfa

Trials by Country

Trials by Country for xopenex hfa
Location	Trials
United States	14

Trials by US State

Trials by US State for xopenex hfa
Location	Trials
Michigan	2
Texas	2
Pennsylvania	2
Arizona	1
Virginia	1

Clinical Trial Progress for xopenex hfa

Clinical Trial Phase

Clinical Trial Phase for xopenex hfa
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for xopenex hfa
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for xopenex hfa

Sponsor Name

Sponsor Name for xopenex hfa
Sponsor	Trials
Sunovion	3
Children's Hospital of Philadelphia	1
ICN Pharmaceuticals	1

Sponsor Type

Sponsor Type for xopenex hfa
Sponsor	Trials
Other	7
Industry	4

Xopenex hfa Market Analysis and Financial Projection

Xopenex HFA: Clinical Trials, Market Analysis, and Projections

Introduction

Xopenex HFA (levalbuterol tartrate) is a short-acting beta2-adrenergic agonist used for the treatment or prevention of bronchospasm in patients with asthma. Here, we will delve into the recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Pediatric Studies

Recent clinical trials have focused on the efficacy and safety of Xopenex HFA in pediatric patients. A supplemental New Drug Application (sNDA) submission included data from a modified-blind, placebo-controlled trial (Study 051-359) that evaluated the effectiveness of Xopenex HFA in patients less than 4 years of age. However, this study failed to meet its primary endpoint, showing no significant difference in the mean Pediatric Asthma Composite Assessment (PACA) score change from baseline compared to the placebo group. Additionally, there was a small but consistent increase in asthma-related treatment-emergent adverse events and treatment discontinuations due to asthma in this age group, which does not support approval for use in pediatric patients under 4 years of age[1].

Adult and Adolescent Studies

For adults and adolescents 12 years of age and older, Xopenex HFA has been evaluated in two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials. These trials compared Xopenex HFA with a marketed albuterol HFA inhaler and an HFA-134a placebo inhaler. The results showed that Xopenex HFA was effective in reducing asthma symptoms, with adverse reaction profiles similar to those of racemic albuterol HFA and the placebo group. Common adverse reactions included asthma, pharyngitis, rhinitis, pain, and dizziness[3][5].

Ongoing and Future Studies

The second PREA-required study (Study 051-361) is planned to evaluate the safety and efficacy of cumulative dosing with Xopenex HFA compared to racemic albuterol for acute asthma exacerbations in patients less than 4 years of age. This study will provide further insights into the use of Xopenex HFA in younger pediatric patients[1].

Market Analysis

Current Market Position

Xopenex HFA is a significant player in the bronchodilators market, particularly within the beta-adrenergic bronchodilators segment. This segment dominated the market in 2022, accounting for more than 40% of the revenue share. Xopenex HFA, along with other short-acting beta2-agonists like albuterol, is widely used for the dilation of bronchial airways in patients with asthma[4].

Market Size and Growth

The global bronchodilators market was estimated at USD 22.19 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030. The beta-adrenergic bronchodilators segment, which includes Xopenex HFA, is expected to grow at a CAGR of 3.33% during this period[4].

Competitive Landscape

The market for bronchodilators is competitive, with several major products including levalbuterol (Xopenex HFA), albuterol (Proair HFA, Proventil HFA, AccuNeb, Ventolin HFA), and epinephrine injection. Recent developments, such as the Phase III clinical trials of PT027 (Albuterol/Budesonide Fixed-Dose Combo), indicate ongoing innovation and competition in the market[4].

Market Projections

Revenue Forecast

Given the steady growth rate of the bronchodilators market, Xopenex HFA is expected to continue contributing significantly to the revenue in this segment. The market is projected to reach USD 28.75 billion by 2030, with the beta-adrenergic bronchodilators segment maintaining its dominant position[4].

Regional Growth

The growth of the bronchodilators market, including Xopenex HFA, is expected to be driven by regions such as North America, Europe, and the Asia Pacific. These regions have a high prevalence of asthma and other respiratory diseases, driving the demand for effective bronchodilators[4].

Generic Entry and Patent Landscape

Xopenex HFA has one patent protecting it, and there have been patent litigation cases indicating strong interest in generic launch. However, as of now, the generic entry has not significantly impacted the market share of Xopenex HFA. The patent landscape and potential generic entries will be crucial factors to monitor in the future[2].

Key Takeaways

• Clinical Trials: Recent pediatric trials did not support the use of Xopenex HFA in patients under 4 years of age, while adult and adolescent trials confirmed its efficacy and safety.
• Market Analysis: Xopenex HFA is a key player in the beta-adrenergic bronchodilators segment, which dominates the bronchodilators market.
• Market Projections: The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030, with Xopenex HFA contributing to this growth.
• Competitive Landscape: The market is competitive, with ongoing innovation and potential generic entries that could impact future market dynamics.

FAQs

What is Xopenex HFA used for?

Xopenex HFA is used for the treatment or prevention of bronchospasm in patients with asthma.

What are the common adverse reactions associated with Xopenex HFA?

Common adverse reactions include asthma, pharyngitis, rhinitis, pain, and dizziness.

Is Xopenex HFA approved for use in pediatric patients under 4 years of age?

No, recent clinical trials did not support the approval of Xopenex HFA for use in pediatric patients under 4 years of age due to lack of consistent efficacy and increased adverse events.

What is the projected growth rate of the bronchodilators market?

The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030.

Are there any ongoing clinical trials for Xopenex HFA?

Yes, a second PREA-required study (Study 051-361) is planned to evaluate the safety and efficacy of cumulative dosing with Xopenex HFA in patients less than 4 years of age.

Sources

1. FDA: N21-730S036 Levalbuterol Clinical BPCA.
2. DrugPatentWatch: XOPENEX HFA Drug Patent Profile.
3. RxList: Xopenex HFA (Levalbuterol Tartrate Inhalation Aerosol).
4. Grand View Research: Bronchodilators Market Size & Trends Analysis Report, 2030.
5. FDA: XOPENEX HFA® (levalbuterol tartrate) inhalation aerosol, for oral inhalation use.