Inhaled salbutamol for wheezy infants: a randomised controlled trial

Background-Salbutamol is frequently used as a bronchodilator for infants wh o wheeze. Many single dose studies have questioned its effectiveness. Aims-To investigate the response of wheezy infants to salbutamol over an ex tended time period in order to elucidate either symptomatic relief or a pro tective effect. Methods-Eighty infants under 1 year, with persistent or recurrent wheeze an d a personal or family history of atopy, were recruited to a randomised, do uble blind, cross over, placebo controlled trial. Salbutamol (200 mu g thre e times daily) or placebo were administered regularly over two consecutive treatment periods of four weeks via a spacer and mask. Symptoms of wheeze a nd cough were recorded in a diary. At the end of the study pulmonary functi on tests were performed before and after salbutamol (400 mu g). Results-Forty eight infants completed the diary study; 40 infants underwent pulmonary function testing. No difference in mean daily symptom score was observed between the salbutamol and placebo periods. There was no differenc e in the number of symptom free days. Compliance and forced expiratory flow s remained unchanged and resistance increased following salbutamol. There w as no relation between the response measured by symptom score or pulmonary function in individual patients. Conclusion-In wheezy infants with an atopic background, there was no signif icant beneficial effect of salbutamol on either clinical symptoms or pulmon ary function. Clinical effects could not be predicted from pulmonary functi on tests. Salbutamol cannot be recommended as the bronchodilator of choice in this age group.