Randomized, double-blind, placebo-controlled trial of oral albuterol in infants with mild-to-moderate acute viral bronchiolitis

J Pediatr. 2003 May;142(5):509-14. doi: 10.1067/mpd.2003.196.


Objective: To determine whether oral albuterol is effective in reducing symptomatology of acute viral bronchiolitis in infants with mild-to-moderate illness.

Study design: In a randomized, double-blind trial, previously well infants were randomized upon discharge from the emergency department to receive either albuterol (0.1 mg/kg/dose) three times per day or placebo three times per day for 7 days. Daily standardized telephone interviews were conducted for as long as 14 days. The primary outcome was the time to resolution of illness. Secondary outcomes included time to normal feeding, normal sleeping, quiet breathing, resolved cough, and coryza.

Results: We studied 129 infants (albuterol, n = 64; placebo, n = 65). Baseline characteristics were similar between groups. The overall mean age was 5.3 months, 60% were male, and 49 of 61 tested infants were positive for respiratory syncytial virus. The median (95% confidence interval) time to resolution of illness (days) was similar: albuterol, 9.0 (8-13); placebo, 8.0 (7-9); P =.3) (log-rank test). There were no significant group differences in any secondary outcome. Health care revisit and admission rates were similar between groups.

Conclusions: No significant group differences in either primary or secondary outcomes in infants treated with oral albuterol versus placebo were found. The widespread use of oral albuterol in this patient group is not recommended.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Oral
  • Albuterol / administration & dosage
  • Albuterol / therapeutic use*
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Bronchiolitis, Viral / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant
  • Male
  • Severity of Illness Index
  • Steroids
  • Time Factors


  • Anti-Inflammatory Agents
  • Steroids
  • Albuterol