Levalbuterol Versus Levalbuterol Plus Ipratropium in the Treatment of Severe Acute Asthma

Abstract

Background. The National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines advise the addition of ipratropium bromide to short-acting β-agonist therapy for the treatment of patients with severe acute asthma exacerbation. Methods. This was a prospective, double-blind, randomized, controlled study involving 141 adults, presenting to two EDs with acute severe asthma exacerbation. Patients were treated using a standardized pathway with levalbuterol plus ipratropium or levalbuterol alone. Primary outcomes were changes from baseline in the percentage of predicted forced expiratory volume in 1 second (FEV₁) at 30 minutes and 60 minutes after completion of treatment. Secondary outcomes included hospitalization and relapse rates. Occurrence of adverse events was recorded. Results. Sixty-seven patients in the levalbuterol plus ipratropium group and 74 patients in the levalbuterol group completed the study. Overall, there was no significant difference in the improvement in percent predicted FEV₁ between the two groups at 30 minutes [difference in change between study groups at 30 minutes: 1% (95% CI: ?3 to 2%) or at 60 minutes: 3% (95% CI: 1–6%)] No difference was noted in hospitalization rates between the treatment groups [combination therapy group, 33%; single therapy group, 47%, difference: −14% (95% CI: −30 to 20%)]. Post-hoc analysis revealed that patients receiving ipratropium in addition to levalbuterol were 1.5 times more likely to experience side effects (palpitations) than patients treated with levalbuterol alone (RR 1.5; 95% CI: 1.2–1.9) No differences in relapse rates were noted between the groups. Post-hoc analysis revealed more side effects in patients receiving levalbuterol plus ipratropium. Conclusion. We were unable to demonstrate superiority of adding ipratropium to levalbuterol in alleviating obstruction as measured by FEV₁ or in decreasing the need for hospitalization among adult patients presenting to the ED with acute severe asthma exacerbation.

Keywords:

• asthma exacerbation
• emergency
• levalbuterol
• ipratropium

Acknowledgments

RKC conceived the study and designed the trial. RKC supervised the conduct of the trial and data collection. RKC, CE, and AM undertook recruitment of patients and managed the data, including quality control. RKC drafted the manuscript, and CE and AM contributed substantially to its revision. RKC takes responsibility for the article as a whole. This study was supported by a grant from Sepracor. The study was entirely designed by Dr. Cydulka and all data were analyzed by Dr. Cydulka.

Declaration of Interest

The study was supported by a grant from Sepracor. The authors alone are responsible for the content and writing of the paper.