SUMMARY
Xopenex® (levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg*
Xopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist.
Xopenex (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.
|
NEWS HIGHLIGHTS
Published Studies Related to Xopenex Inhalation (Levalbuterol Inhalation)
A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. [2008.09]
BACKGROUND: The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). OBJECTIVE: This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects... CONCLUSION: In this study single-day cumulative dosing of asthmatic subjects with levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV(1) and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with levalbuterol HFA MDI.
Chronic inhalation of nebulized levalbuterol does not increase mucociliary clearance in healthy subjects. [2008]
Acute inhalations of beta 2-adrenergic receptor agonists increase mucociliary clearance (MCC). Less is known about the effect of long-term inhalations of these agents on MCC, or cough clearance (CC)... These results indicate that chronic inhalations of nebulized levalbuterol for 1 week do not increase MCC or CC in healthy subjects, compared to albuterol or placebo.
Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. [2007.12]
BACKGROUND: Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol. OBJECTIVE: To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma... CONCLUSION: In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.
An evaluation of levalbuterol HFA in the prevention of exercise-induced bronchospasm. [2007.11]
BACKGROUND: Exercise-induced bronchospasm (EIB) affects up to 90% of all patients with asthma. Objective. This study evaluated the ability of levalbuterol hydrofluoroalkane (HFA) 90 mug (two actuations of 45 microg) administered via metered dose inhaler (MDI) to protect against EIB in mild-to-moderate asthmatics... CONCLUSION: Levalbuterol HFA MDI (90 microg) administered 30 minutes before exercise was significantly more effective than placebo in protecting against EIB after a single exercise challenge and was well tolerated. CLINICAL IMPLICATIONS: Levalbuterol HFA MDI when administered before exercise was effective in protecting adults with asthma from EIB.
Chronic inhalation of nebulized levalbuterol does not increase mucociliary clearance in healthy subjects. [2007.01.25]
Acute inhalations of beta(2)-adrenergic receptor agonists increase mucociliary clearance (MCC). Less is known about the effect of long-term inhalations of these agents on MCC, or cough clearance (CC)... These results indicate that chronic inhalations of nebulized levalbuterol for 1 week do not increase MCC or CC in healthy subjects, compared to albuterol or placebo.
Clinical Trials Related to Xopenex Inhalation (Levalbuterol Inhalation)
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma [Completed]
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA
metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years
of age with asthma
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD) [Completed]
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol
compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48
months old.
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients [Active, not recruiting]
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA
Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered
dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:
1. Placebo control: (HFA propellant only, Treatment P); and
2. Active control: 3M/Key's Proventil-HFA (Treatment R).
The treatments will be given as self-administered oral inhalations in adult and adolescent
patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week
study is two actuations four times daily (QID).
Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma [Completed]
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children [Completed]
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.
|
