Oral Albuterol Is of No Benefit for Infants with Bronchiolitis

Source: Patel I, Gouin S, Platt RW. Randomized, double-blind, placebo-controlled trial of oral albuterol in infants with mild-to-moderate acute viral bronchiolitis. J Pediatr. 2003;142:509–514.Oral albuterol is commonly prescribed to outpatients with bronchiolitis, despite the lack of evidence to support its efficacy.1 Researchers from McGill University and St. Justine Hospital in Montreal, Quebec, Canada, performed a randomized placebo-controlled study to determine if oral albuterol was effective in reducing symptoms of viral bronchiolitis in infants with mild to moderate disease. Infants were seen in the pediatric emergency department (ED) over 3 consecutive bronchiolitis seasons. Eligible patients included previously healthy infants less than 1 year of age with a clinical diagnosis of acute viral bronchiolitis who were being discharged home. Before discharge, patients received either a single dose of oral albuterol (0.1 mg/kg) or an oral placebo that was identical in its color, taste, and volume. Both groups were instructed to continue the same medication dose 3 times daily for 7 days or until complete resolution of symptoms. Daily structured telephone interviews were conducted either until the infant had complete resolution of symptoms or until 14 days after enrollment. Caregivers of all infants had a final follow-up phone call at 14 days. The main outcome measure was time to resolution of illness (ROI), which was defined as the period from study enrollment to the time that the infant returned to baseline health (as determined by the principal caregiver). Secondary outcome measures included duration of cough, coryza, noisy breathing, time to normal feeding, and time to normal sleeping. Adverse events and potential side effects (including tremor and vomiting) were also monitored.During the 3-year study period (1998–2001), 129 infants were enrolled (64 albuterol and 65 placebo). The mean age (SD) in months was 5.4 (3.1) for albuterol and 5.1 (2.6) for placebo. RSV was the most common pathogen found among those who were tested (albuterol, 26/32, 81%; placebo 23/29, 79%). Both groups had been ill a median of 4 days prior to presentation. There was no difference in the mean number of days [SD] to ROI between the 2 groups (albuterol 8.9 [4.0]; placebo 8.4 [3.7] [t test P=.5]). There were also no significant differences in any of the secondary outcomes. Four infants in the albuterol group eventually required admission to the hospital compared to 5 infants in the placebo group. The median number of days (quartile range) in which trembling was observed was 0 (0–2) for albuterol and 0 (0) for placebo. The median number of days (quartile range) in which the infant vomited was 1.0 (0–3) for albuterol and 1.0 (0–2) for placebo. The number of primary caregivers who reported missed workdays was the same for each group.A previous study found no benefit from oral albuterol in the treatment of infants with bronchiolitis, but it looked only at short-term effects at 30 and 60 minutes.2 The current study looked at effects over 7 days and included an assessment of symptoms that are important to parents including cough, coryza, poor feeding, noisy breathing, vomiting, and tremors. It is not surprising that duration of illness was the same in both groups, as it is generally accepted that bronchodilators do not change the clinical course of bronchiolitis.3 However, this well-designed study also confirms that oral albuterol does not relieve the clinical symptoms associated with this viral disease. The study did not have enough power to determine if the albuterol group had more side effects, but it is interesting to note that of the 5 patients who discontinued the treatment during the study period, 3 did so because of the negative side effects of albuterol. A previous study showed an increase in heart rate (mean of 15 beats per minute) in patients receiving oral albuterol.2 Nebulized albuterol has not been studied as a home treatment for infants with bronchiolitis. Even in hospitalized patients with moderate to severe disease, studies of its effectiveness have either shown no effect or only a modest short-term benefit.4 A recent multicenter study of nebulized epinephrine could not demonstrate clinically relevant improvement or reduced length of stay in infants aged less than 1 year with acute bronchiolitis.5 Until an effective treatment for viral bronchiolitis is discovered, physicians and parents will have to rely on supportive therapy (oxygen, hydration) for patients with mild to moderate disease.

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