A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of
nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will
lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of
levalbuterol alone every 20 minutes.
The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol
in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater
bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone
every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol
and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with
acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship
between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1,
(2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on
presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%,
30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.