Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Chest. 2006;130:487–492
PURPOSE OF THE STUDY. To determine the feasibility of aerosol administration with a metered-dose inhaler (MDI) spacer in sleeping young children.
STUDY POPULATION. Thirty children (18 boys) from the Netherlands between 6 and 23 months of age were treated with inhalation therapy twice per day for recurrent wheezing in the previous month.
METHODS. Parents were trained to use a metal chamber (NebuChamber) with a face mask to administer 200 μg of budesonide aerosol. A filter was placed between the spacer and face mask to trap and then measure the aerosol inhaled from the spacer. The study included 1 run-in week and 2 test weeks. The families were visited at home 4 times in the 3 weeks. At the 1-week run-in, the parents practiced the procedure with a placebo MDI while the child was awake. In weeks 2 and 3, they administered 1 puff while the child was awake (awake administration), 1 puff before bedtime, and 1 puff while the child was asleep (sleep administration). Parents then were asked to score the child's asthma symptoms and degree of cooperation and the feasibility of administration. Filters were washed, and budesonide amounts were measured by high-performance liquid chromatography and spectrophotometry.
RESULTS. Twenty-one children fully completed the study, and a total of 350 awake-administration filters and 331 sleep-administration filters were collected. The mean filter dose was significantly higher for awake administration (47% ± 26%) than that for sleep administration (16% ± 13%). The median variability dose for awake administration was 50%, whereas it was 110% for sleep administration. Poor cooperation was noted for 29% of the awake administrations. In 69% of the sleep administrations, the child woke up, and in 75% of these cases, the child was distressed. Twenty-two percent of parents reported mask-positioning problems while the child was sleeping. Mean symptoms scores were 1.4 ± 2.2 (0 = no symptoms, 4 = severe symptoms; maximum score = 12 for sum of cough, wheeze, and shortness of breath).
CONCLUSIONS. Administering aerosol therapy during sleep has been suggested as a way to overcome cooperation problems in young children, but this study suggests that this is not the answer.
REVIEWER COMMENTS. The study included 30 children, and only 21 completed the study; a larger study would need to be performed with design modifications. One significant concern about the study design is that the children did not receive active drug during the study because the design required capturing the drug in a filter to determine drug delivery (which may explain the high drop-out rate). Furthermore, the design of the study did not allow for a means to determine clinical efficacy or lung deposition of the drug. In the interim, pediatricians may want to reconsider recommending dosing of aerosolized medications during sleep.
- Copyright © 2007 by the American Academy of Pediatrics