NEWS HIGHLIGHTS
Published Studies Related to Ventolin HFA (Albuterol HFA)
Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo controlled trial. [2009.07.16]
INTRODUCTION: Inhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population... CONCLUSION: This study provides additional albuterol HFA safety information for the treatment of children aged birth </=24 months with a history of bronchospasm.
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.
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.
Dose-response to salbutamol via a novel palm sized nebuliser (Aerodose Inhaler), conventional nebuliser (Pari LC Plus) and metered dose inhaler (Ventolin Evohaler) in moderate to severe asthmatics. [2005.01]
AIMS: The Aerodose inhaler is a novel, palm-sized, breath actuated device which requires little patient coordination. This study compared the dose-response of salbutamol delivered by the Aerodose Inhaler (Aerogen Inc., Mountain View, USA) vs Pari LC Plus jet nebulizer (Pari LC Plus; Pari GmbH, Starnberg, Germany) and Ventolin Evohaler HFA pMDI (Evohaler; Allen & Hanburys [GlaxoSmithkline], Uxbridge, UK)... CONCLUSIONS: This study has indicated therefore, that Aerodose Inhaler is approximately five times as efficient as the Pari LC Plus and Evohaler in relative lung delivery of salbutamol in moderate to severe asthmatics.
Clinical Trials Related to Ventolin HFA (Albuterol HFA)
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]
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects [Completed]
An analysis of the costs and outcomes associated with hospitalization and treatment of
Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.
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