A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Detailed description: 
      Patients will then receive, in a randomized double-blinded fashion, levalbuterol, 1.25mg
      every 20 minutes for a total of 3 aerosolized doses combined with ipratropium, 0.5mg every 20
      minutes for a total of 3 aerosolized doses. The medication will be premixed by the pharmacy
      in a total of 3 ml of normal saline and the nebulizer will be driven with oxygen at 6 liters
      per minute. A second plasma sample for analysis of albuterol isomers will be drawn within a
      fifteen minute window following the third aerosol treatment. Spirometry will be repeated
      again at 30 and 60 minutes after the third aerosol treatment (Figure 1). All patients will
      receive prednisone, 60mg orally immediately after their first dose of aerosolized
      medications, unless contraindications to prednisone administration are present. Patients will
      not receive any other medications during the time course of the study. Vital signs and pulse
      oximetry will be repeated prior to each nebulized treatment and again 30 minutes after the
      third nebulized treatment.

      The study will terminate 60 minutes after the third aerosol administration. At that point,
      any further therapy will be at the discretion of the treating physician. Patients will be
      questioned about the occurrence of any side effects from levalbuterol treatment including
      palpitations, anxiety, nausea, vomiting or headache. Patients will also be questioned about
      the occurrence of any side effects from ipratropium, including dry mouth, dry eyes, and
      urinary retention. Patients will be withdrawn from the study at any point these side effects
      become intolerable to the patient or any time the patient so desires. Patients will also be
      withdrawn if they develop palpitations and have an ECG that demonstrates ventricular or
      supraventricular tachycardia.

      .Patients will be called 14 days after their ED visit to assess relapse or recurrence of
      acute asthma exacerbation. In addition, a chart review will be performed to assess relapse or
      recurrence of acute asthma exacerbation, as well as determine hospital length of stay in
      those patients who required admission after the initial visit.
    

Intervention name(s): ipratropium
Intervention type(s): Drug
Intervention description(s): 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
Intervention MeSH terms: Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Bronchodilators; Levalbuterol; Ipratropium