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.
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.


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


METHODS
Pediatric emergency wards at 2 tertiary teaching hospitals.


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


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


METHODS
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-microg/kg doses of albuterol administered through the spacer device should be considered in hospital emergency departments as first-line therapy for wheezing.
Service d'Urgence et de Réanimation Pédiatrique, Hôpital Edouard Herriot, Hospices Civils, Lyon, France.
D
D
Ploin
F R
FR
Chapuis
D
D
Stamm
J
J
Robert
L
L
David
P G
PG
Chatelain
G
G
Dutau
D
D
Floret
D000208:Acute Disease; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D012008:Recurrence; D012135:Respiratory Sounds / Q000187:drug effects*; D013810:Therapeutic Equivalency
D001993:Bronchodilator Agents; D000420:Albuterol