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PEDIATRICS Vol. 106 No. 2 August 2000, pp. 311-317

High-Dose Albuterol by Metered-Dose Inhaler Plus a Spacer Device Versus Nebulization in Preschool Children With Recurrent Wheezing: A Double-Blind, Randomized Equivalence Trial

Received May 17, 1999; accepted Dec 16, 1999.

Dominique Ploin*, Dagger , François R. Chapuis§, Didier Stamm*, Jacques Robertparallel , , Louis David, Pierre G. ChatelainDagger , Guy Dutau#, and Daniel Floret*

From the * Service d'Urgence et de Réanimation Pédiatrique, Hôpital Edouard Herriot, Hospices Civils, Lyon, France; Dagger  Unité d'Accueil des Urgences Pédiatriques, Hôpital Debrousse, Hospices Civils, Lyon, France; § Unité de Recherche Clinique, Département d'Information Médicale, Hospices Civils, Lyon, France; parallel  63 Bis rue de la République, F-69150 Décines Charpieu, France;  Département de Pédiatrie, Hôpital Edouard Herriot, Hospices Civils, Lyon, France; and # Service de Pneumologie-Allergologie Pédiatrique, Hôpital des Enfants, Toulouse, France.

Inhaled albuterol is the most frequently used bronchodilator for acute wheezing, and nebulization is the standard mode of delivery in hospital setting. However, recent guidelines consider spacer devices as an easier to use, and cost-saving alternative and recommend the high-dose metered-dose inhaler bronchodilator.

Objective.  To demonstrate clinical equivalence between a spacer device and a nebulizer for albuterol administration.

Design.  Randomized, double-blind, parallel group equivalence trial.

Setting.  Pediatric emergency wards at 2 tertiary teaching hospitals.

Patients.  Sixty-four 12- to 60-month-old children with acute recurrent wheezing (32 per group).

Interventions.  Albuterol was administered through the spacer device (50 µg/kg) or through the nebulizer (150 µg/kg) and repeated 3 times at 20-minute intervals. Parents completed a questionnaire.

Outcome Measures.  Pulmonary index, hospitalization, ease of use, acceptability, and pulse oximetry saturation.

Results.  The 90% confidence interval of the difference between treatment groups for the median absolute changes in pulmonary index values between T0 and T60 was [-1; +1] and was included in the equivalence interval [-1.5; +1.5]. Clinical improvement increased with time. Less than 10% of the children (3 in each group) required hospitalization (2 in each group attributable to treatment failure). Parents considered administration of albuterol using the spacer device easier (94%) and better accepted by their children (62%).

Conclusions.  The efficacy of albuterol administered using the spacer device was equivalent to that of the nebulizer. Given its high tolerance, repeated 50-µg/kg doses of albuterol administered through the spacer device should be considered in hospital emergency departments as first-line therapy for wheezing.

 Key words:  recurrent wheezing, asthma, preschool children, inhaled albuterol, spacer device, metered-dose inhaler, nebulizer, equivalence trial, randomized trial, acceptability.




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