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Addition of Ipratropium to Albuterol and Corticosteroid Does Not Benefit Children Hospitalized Because of an Acute Asthma Exacerbation

Question

  • Is ipratropium added to inhaled albuterol and systemic corticosteroids beneficial in patients hospitalized with an asthma exacerbation?

Clinical Bottom Lines

  1. Adding ipratropium to albuterol and corticosteroids after an admission for an asthma exacerbation does not confer any additional benefit.


Summary of Key Evidence

  1. Double-blind, randomized, placebo-controlled trial in a pediatric ward of a tertiary care facility.1
  2. 84 children were randomized to receive either ipratropium 250 mcg or normal saline nebulized treatments in addition to albuterol and systemic steroids.
  3. Primary outcome was a clinical asthma score including: respiratory rate, wheezing, inspiratory-expiratory ratio, retractions, observed dyspnea. This was measured at randomization and every 6 hours up to discharge or 36 hours. Secondary outcomes: O2 sat, FEV1 (in children capable of spirometry), doses of inhaled study drug, time to inhaled drug dosing of 4 hours and length of hospitalization.
  4. Results: Both ipratropium and placebo groups had similar clinical asthma score improvement. Neither group had a significant difference in the secondary outcomes.

    Outcome Ipratropium Placebo P-value

    Clinical Asthma Score:
    baseline
    36 hours

    6.1(+/-1.5)
    2.4(+/-1.9)
    5.7(+/-1.4)
    2.6(+/-2.0)
    p=0.07 over time
    O2 Saturation     p=0.16
    FEV1     p=0.62
    Time to 4hr dosing 23h (15-37) 22h (15-39) p=0.73
    Length of stay 42h (31-67) 38h (24-47) p=0.34

Additional Comments

  • 4 children of the initial 84 were withdrawn for not meeting initial inclusion criteria. 1 patient in placebo group was withdrawn for worsening clinical condition. This patient was included in intention-to-treat analysis.
  • All patients had received intensive therapy in Emergency Department(ED) prior to being enrolled. ED treatment was statistically similar and included albuterol (mean of 8 treatments) and ipratropium (mean of 6 treatments).
  • Flaw: Clinical asthma score is a subjective measurement used here as a surrogate for asthma severity. There is high interrater reliability as well as strong correlation with both length of hospital stay and drug-dosing intervals; however, this is still a subjective score assessed by up to 7 different people in each child.
  • Flaw: Only 19% of patients were able to reliably perform spirometry for FEV1, so that secondary endpoint may not be valid.
  • Ipratropium has been shown to be useful in the emergency department and can prevent hospitalization.

Citation

  1. Arch Pediatr Adolesc Med. 2001; 155: 1329-1334.

CAT Author: Jennifer Walker, MD

CAT Appraisers: Robert Schumacher, MD

Date appraised: July 15, 2002

Last updated January 27, 2003
Department of Pediatrics and Communicable Diseases
© 1998-2002 University of Michigan Health System