NEWS HIGHLIGHTS
Published Studies Related to Xopenex HFA (Levalbuterol)
Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial. [2011.03]
OBJECTIVE: To compare racemic albuterol (RAC) with levalbuterol (LEV) in continuous form for the treatment of acute pediatric asthma exacerbations in the emergency department... CONCLUSIONS: At the doses used, RAC appears to be superior to LEV with respect to changes in FEV1 and asthma score. There was no significant difference between the drugs with respect to admission rates or side-effect profile.
Efficacy of racemic albuterol versus levalbuterol used as a continuous
nebulization for the treatment of acute asthma exacerbations: a randomized,
double-blind, clinical trial. [2011]
emergency department... CONCLUSIONS: At the doses used, RAC appears to be superior to LEV with respect to
Levalbuterol versuss levalbuterol plus ipratropium in the treatment of severe acute asthma. [2010.12]
BACKGROUND: The National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines advise the addition of ipratropium bromide to short-acting beta-agonist therapy for the treatment of patients with severe acute asthma exacerbation... CONCLUSION: We were unable to demonstrate superiority of adding ipratropium to levalbuterol in alleviating obstruction as measured by FEV or in decreasing the need for hospitalization among adult patients presenting to the ED with acute severe asthma exacerbation.
High-dose continuous nebulized levalbuterol for pediatric status asthmaticus: a randomized trial. [2009.08]
OBJECTIVE: To assess the use of high-dose continuous levalbuterol (LEV), the single active (R)-enantiomer of racemic albuterol (RAC), in the treatment of status asthmaticus... CONCLUSIONS: Substituting high-dose continuous LEV for RAC did not reduce the time on continuous therapy and had similar adverse effects in children who had failed initial treatment with RAC.
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.
Clinical Trials Related to Xopenex HFA (Levalbuterol)
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.
Reports of Suspected Xopenex HFA (Levalbuterol) Side Effects
Implantable Defibrillator Insertion (1),
Hypersensitivity (1),
Adverse Drug Reaction (1),
Tachycardia (1),
Ventricular Arrhythmia (1),
Hypokalaemia (1),
Haematocrit Decreased (1),
Laboratory Test Abnormal (1),
Road Traffic Accident (1),
Food Allergy (1), more >>
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