IngentaConnect Long-term safety study of levalbuterol administered via metered-d...

Authors: Hamilos, Daniel L.; D'Urzo, Anthony; Levy, Robin J.; Marcus, Michael; Tripp, Kenneth; Parsey, Merdad; Baumgartner, Rudolf A.; McVicar, William K.

Source: Annals of Allergy, Asthma and Immunology, Volume 99, Number 6, December 2007 , pp. 540-548(9)

Publisher: American College of Allergy, Asthma, & Immunology

Abstract:

Background: Previous studies have raised concerns regarding the safety of regular use of β₂-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.

Methods: Patients with mild to moderate asthma (mean forced expiratory volume in 1 second [FEV₁], 68.3% of predicted) 12 years or older participated in a multicenter, parallel-group, open-label study. Patients were randomized to levalbuterol HFA MDI (90 μg; 2 actuations of 45 μg; n = 496) or racemic albuterol HFA MDI (180 μg; 2 actuations of 90 μg; n = 250) for 52 weeks of 4 times daily dosing. The primary end point was the incidence of postrandomization adverse events. Asthma exacerbations and pulmonary parameters were also assessed.

Results: The overall incidence of adverse events was similar for levalbuterol (72.0%) and racemic albuterol (76.8%). Rates of β-mediated adverse events, serious adverse events, and discontinuations because of adverse events were low (<15%) and were comparable between groups. Rates of asthma adverse events for levalbuterol and racemic albuterol were 18.3% and 19.6%, respectively. Mean percentage of predicted FEV₁ improved after dosing and was stable for both groups.

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.

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Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma