Purpose of the Study. To investigate the effect of inhaled fluticasone in a group of infants with significant wheezing at high risk of progressing to childhood asthma.
Study Population. A total of 52 infants between the ages of 3 to 12 months were recruited. Only 37 completed the study.
Methods. Study entry criteria also included a documented history of persistent wheeze, occurring at least 3 days/week for 6 weeks, persistent cough, occurring at least 3 nights/week for 6 weeks, or wheeze, occurring at least 3 times over the previous 3 months. Each child had either a personal history of eczema or a family history of allergy in a first degree relative. None of these children had been on inhaled corticosteroids. If oral steroids had been used, entry into the study was delayed 1 month after the steroid treatment. The study design was double-blinded, randomized, and placebo-controlled. After a 2-week run-in period, the infants were randomized to receive either fluticasone propionate 150 μg as 3 puffs of 50 μg/puff twice a day using a spacer device or an identical placebo for 12 weeks. Albuterol by metered-dose inhaler was available for relief. Parents recorded symptoms of cough and wheeze twice a day. The symptoms were scored 0 to 3. Outcome measures were the mean daily symptom score and the number of symptom-free days. Pulmonary function testing was performed only at baseline. Serum immunoglobulin E (IgE) levels were also obtained during the run-in.
Results. Three groups were compared, those receiving fluticasone, those on placebo, and those who dropped out of the study. There were no differences between the groups in regard to number, sex, age, presenting symptoms, history of eczema, IgE level, family history of allergy, smoke exposure, or the presence of pets. In the fluticasone group, the average age was 9.8 months, 13/19 were males, 7/19 had eczema, 7/19 were exposed to parental smoke, and 9/19 had pet exposure. In the control group, the average age was 8.9 months, 14/18 were male, 9/18 had eczema, 7/18 were exposed to smoke, and 11/18 had pets. Only 27 infants underwent pulmonary function testing and there was no difference between the groups at baseline in their pulmonary function. There was a significant decrease in the fluticasone group in mean daily symptom scores at the end of the study compared with baseline and a significant difference when compared with the placebo group. At the end of the study, the symptom scores decreased 0.95/day with fluticasone while in the placebo group, the daily symptom score increased 0.17. There was also a significant increase in symptom-free days with fluticasone compared with baseline and compared with placebo. Growth parameters revealed a trend to slower weight gain and length in the fluticasone group. This was not found to be of statistical significance.
Conclusion. Symptom scores and symptom-free days were significantly improved with fluticasone in infants who had persistent disease and had a tendency towards allergy.
Reviewer’s Comments. This has all the problems of being a small and relatively short-term study, however, they did a very nice job at looking at a very specific population. This is a population of infants that can be most vexing to the pediatrician. What to do with the wheezing infant? What can be offered and in which infants will it work? Previous studies on the use of inhaled corticosteroids frequently included wide ranges of age and those who were without a predisposition to allergy. The clinical impact was variable leaving unanswered the question of the role of inhaled corticosteroids in young children. These infants were able to use a spacer device and a metered-dose inhaler. By the end of the study, there were 3.84 more symptom-free days over the previous 2 weeks as compared with the placebo group. Obviously more and longer studies of this sort are needed to help in the care of the wheezy infant.
- Chavasse RJ, Bastian-Lee Y, Richter H, Hilliard T, Seddon P. Arch Dis Child.2001;85 :143– 148
- Copyright © 2002 by the American Academy of Pediatrics