Patel H, Gouin S, Platt R. J Pediatr. 2003;142:509–514
Purpose of the Study.
To determine whether oral albuterol therapy is effective in reducing symptoms of mild/moderate acute viral bronchiolitis.
A total of 129 previously healthy infants (≤12 months of age) discharged directly home from the emergency department (ED), with a clinical diagnosis of acute viral bronchiolitis, were studied.
At discharge from the ED, patients were randomly assigned to receive either oral albuterol therapy (0.1 mg/kg per dose) or oral placebo treatment. Infants were treated 3 times daily for a maximum of 7 days or until complete resolution of bronchiolitis symptoms, whichever happened first. Overall health, medication compliance, feeding and sleeping patterns, follow-up visits, parental life disruptions, and adverse events were discussed in daily telephone interviews until the resolution of symptoms or for 14 days. The primary outcome of interest was the time from study enrollment until the resolution of illness, as determined by the primary caregiver. Secondary outcomes of interest included duration of cough, coryza, and noisy breathing, time to normal feeding, and time to normal sleeping.
During the study, 1039 infants were discharged from the hospital ED with acute viral bronchiolitis. Of those, 231 were eligible and 129 were randomized into the study. The mean ages were 5.4 months for the albuterol group and 5.1 months for the placebo group. Respiratory syncytial virus was the pathogen found most frequently (albuterol: 81%; placebo: 79%) in nasopharyngeal aspirates collected from 61 infants in the 2 groups. The median number of days of illness before ED presentation for both groups was 4.0 days. The mean times to the resolution of illness were similar for the 2 groups (albuterol: 8.9 days; placebo: 8.4 days). There were no significant differences in secondary outcomes between the groups. Hospitalization for treatment of respiratory distress was eventually required for 4 infants in the albuterol group and 5 in the placebo group. There were similar median numbers of health care revisits for the 2 groups (albuterol: 1; placebo: 0). There were also similar median numbers of days in which trembling and vomiting were observed (albuterol: 0 and 1; placebo: 0 and 1, respectively).
There was no significant difference in symptom resolution for newly diagnosed bronchiolitis treated with orally administered albuterol versus placebo. The authors did not recommend the use of orally administered albuterol for this patient population.
Although previous studies found similar results, most outcomes in this study were based solely on subjective evaluations by the primary caregiver at home. The authors present compelling evidence that orally administered albuterol, at the dose used in this study, has little role in the treatment of bronchiolitis among infants. However, the dose of albuterol was at the low end of the recommended dose range of 0.1 to 0.2 mg/ kg per dose, administered 3 times daily.