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Oral Salbutamol Ineffective for Acute Viral Bronchiolitis in Infants: Presented at CPS

By Pippa Wysong
Special to DG News

TORONTO, ON -- June 14, 2002 -- Oral salbutamol for the treatment of acute viral bronchiolitis in infants may not be as effective or appropriate as physicians think.

Infants brought to the emergency department are commonly put on a course of the drug, yet there is little evidence to support its use, said Dr. Hema Patel, of the Montreal Children's Hospital, Montreal, Quebec, Canada. She presented the findings here at the 79^th Annual Meeting of the Canadian Paediatric Society (CPS) here.

"Acute viral bronchiolitis is the most common lower respiratory tract infection of infancy and occurs in epidemic fashion every winter," she said, adding that large numbers of cases typically show up in emergency departments each year.

Survey studies and pharmacy prescription databases reveal that oral bronchodilators are commonly prescribed for this patient group, with salbutamol frequently being prescribed three times daily for five to seven days.

"Even though it is commonly used, we were only able to find two previously published trials that examined the effects of oral bronchodilators in infants with acute bronchiolitis," Dr. Patel said. This triggered researchers to do a randomised, controlled trial to see whether therapy with the oral bronchodilator was more effective than no treatment at all.

A study was launched at Montreal Children's Hospital in which infants with mild to moderate acute viral bronchiolitis and first-time wheezing were randomised to oral salbutamol (0.1 mg/kg tid) or placebo for seven days during the 1999 and 2000 winter seasons. The primary outcome for the study was time to resolution of illness, measured in days.

Exclusion criteria included infants who were hospitalized, were born at less than 34 weeks gestation, or had other respiratory conditions.

A total of 231 outpatient infants treated in the emergency department were eligible for the study. Of these, 60 were excluded because parental consent was not attained, and another 42 were excluded because consent was not attained from treating physicians.

Dr. Patel said some emergency department physicians felt strongly that their patients be given salbutamol and not placebo and would not agree to have their patients entered in the study.

This left 129 patients in the study: 65 were randomised to salbutamol and 64 to placebo. The mean age of the infants was 4.6 months, 60 percent were boys, and 76 percent tested positive for respiratory syncytial virus.

The Respiratory Distress Assessment Instrument was used to assess the severity of disease both at baseline and follow-up.

The salbutamol group had a mean resolution time of 9 days, compared to just over 8 days for the placebo group. "There was no difference between the groups," Dr. Patel said.

In general, the course to recovery, including how well the infants slept through nights and how often they coughed, "was very similar in both groups," she said.

As far as the researchers know, this is the first randomised, placebo-controlled trial of a treatment course of salbutamol in this population.

"The widespread practice of oral salbutamol use in this patient group is not recommended," Dr. Patel said.

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