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

Clinical Trial Conditions for XOPENEX HFA

Condition Name

Condition Name for XOPENEX HFA
Intervention	Trials
Asthma	3
COPD	1
Hematological Malignancies	1
Sepsis	1

Condition MeSH

Condition MeSH for XOPENEX HFA
Intervention	Trials
Asthma	3
Hematologic Neoplasms	1
Status Asthmaticus	1
Respiratory Tract Infections	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
Texas	2
Pennsylvania	2
Michigan	2
South Carolina	1
Oregon	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 (levalbuterol tartrate) Clinical Trials Update and Market Outlook

Last updated: April 28, 2026

What is XOPENEX HFA and who uses it?

XOPENEX HFA is an inhaled short-acting beta2-agonist (SABA) delivered via metered-dose inhaler (MDI). It contains levalbuterol tartrate as the active ingredient and is used as a bronchodilator for the treatment or prevention of bronchospasm associated with reversible obstructive airway disease (including asthma and COPD), typically on a “rescue” basis.

In the US, XOPENEX HFA sits in a crowded SABA category dominated by albuterol products (both branded and authorized generics). Competitive dynamics are driven by:

• Price and formulary positioning versus generic albuterol MDIs
• Switchability across SABAs (clinical interchangeability for many rescue indications)
• Payer preference for lower-cost alternatives
• Device-specific factors (patients and payers may differentiate MDI vs nebulizer; within MDIs, cost usually dominates)

What clinical trial developments exist for XOPENEX HFA?

No complete, current “clinical trials update” can be produced here. A compliant, complete update requires at minimum: study identifiers (NCT numbers), key endpoints (FEV1 onset, peak response, duration), results (numerical effect sizes), and trial status dates. That information is not present in the request and cannot be derived without external trial registries and primary publications.

How does XOPENEX HFA compete in the SABA market?

Competitive set (practical)

XOPENEX HFA competes primarily against:

• Generic albuterol MDIs (substitution-driven, lowest cost)
• Branded albuterol offerings where managed care has not fully forced generic substitution
• Other levalbuterol formulations (where covered) depending on payer and device preference

Competitive drivers

• Generic penetration: albuterol is widely generic; payers push cost control for rescue therapy.
• Formulary rules: step edits and substitution policies often favor the lowest-cost SABAs.
• Clinical equivalence perception: in routine rescue use, inhaled beta2-agonists are treated as therapeutically similar, shifting value toward cost, access, and coverage.
• Patient/device handling: inhaler technique is a known determinant of real-world bronchodilation. However, across MDIs, differentiation usually does not outweigh cost unless a patient-specific problem exists.

What market metrics matter for projection?

A credible projection for XOPENEX HFA requires baseline units/revenue, scripts, net price, and volume trends by payer segment, plus competitor and guideline effects. That dataset is not provided, and the prompt does not include product-level sales, share, or prescription data. Without those, a numerical market projection cannot be calculated.

What an investment-grade model would normally include

Even absent numbers, a correct projection framework for this category typically ties:

• US retail and mail-order IMS-style prescriptions for SABAs
• Net price trajectory tied to generic erosion and rebates
• Formulary coverage changes (preferred SABA lists, DUR edits, step edits)
• Share shifts due to competitive launches or policy changes
• Form-factor mix (MDI vs nebulizer; MDI adherence vs technique)
• Seasonality (winter respiratory peaks in many geographies)

Can XOPENEX HFA’s outlook be projected without new data?

No. A projection requires at least one of the following: historical sales/revenue trend, prescription share trend, or explicit analyst market sizing inputs. The request includes none, so any numeric outlook would be non-actionable and non-verifiable.

Key Takeaways

• XOPENEX HFA is a levalbuterol tartrate MDI used as a rescue bronchodilator for reversible obstructive airway disease.
• Clinical trial “updates” require study-level identifiers and results; none are supplied here, and a complete update cannot be produced.
• Market positioning is cost- and formulary-driven within a generic-dominated SABA category, where albuterol products set the baseline pricing and access.
• A quantitative market projection cannot be produced without product-level historical performance or market sizing inputs.

FAQs

1. What active ingredient is in XOPENEX HFA?
   Levalbuterol tartrate.

2. What is XOPENEX HFA used for?
   Treatment or prevention of bronchospasm associated with reversible obstructive airway disease (including asthma and COPD), as a bronchodilator.

3. What is the competitive environment for XOPENEX HFA?
   Generic and branded albuterol MDIs plus other SABA options, with payer-driven substitution toward lower-cost products.

4. Why does XOPENEX HFA pricing face pressure?
   Albuterol SABAs have high generic availability, and managed care tends to prefer lowest net-cost rescue therapy.

5. Can a sales or volume projection be produced from this prompt alone?
   No. A projection requires historical sales/scripts/net price data or explicit market sizing inputs, none of which are provided.

References

[1] FDA. Drug Label Information for XOPENEX HFA (levalbuterol tartrate). (Regulatory labeling source for indication and dosing).
[2] FDA. Generic and Reference Product Guidance and substitution frameworks impacting branded vs generic respiratory rescue therapies.