Regular vs prn nebulized treatment in wheeze preschool children.
BACKGROUND
International guidelines recommend regular treatment with inhaled glucocorticoids for children with frequent wheezing; however, prn inhaled bronchodilator alone or in combination with glucocorticoid is also often used in practice. We aimed to evaluate whether regular nebulized glucocorticoid plus a prn bronchodilator or a prn nebulized bronchodilator/glucocorticoid combination is more effective than prn bronchodilator alone in preschool children with frequent wheeze.


METHODS
Double-blind, double-dummy, randomized, parallel-group trial. After a 2-week run-in period, 276 symptomatic children with frequent wheeze, aged 1-4 years, were randomly assigned to three groups for a 3-month nebulized treatment: (1) 400 microg beclomethasone bid plus 2500 microg salbutamol prn; (2) placebo bid plus 800 microg beclomethasone/1600 microg salbutamol combination prn; (3) placebo bid plus 2500 microg salbutamol prn. The percentage of symptom-free days was the primary outcome measure. Secondary outcomes included symptom scores, use of relief medication and exacerbation frequency.


RESULTS
As compared with prn salbutamol (61.0 +/- 24.83 [SD]), the percentage of symptom-free days was higher with regular beclomethasone (69.6%, SD 20.89; P = 0.034) but not with prn combination (64.9%, SD 24.74). Results were no different in children with or without risk factors for developing persistent asthma. The effect of prn combination was no different from that of regular beclomethasone on the primary and on several important secondary outcomes.


CONCLUSIONS
Regular inhaled glucocorticoid is the most effective treatment for frequent wheezing in preschool children. However, prn bronchodilator/glucocorticoid combination might be an alternative option, but it requires further study.
Papi
A
A
Department of Respiratory Diseases, Research Center on Asthma and COPD, University of Ferrara, Ferrara, Italy.
Nicolini
G
G
Medical Department, Chiesi Farmaceutici, Parma, Italy.
Baraldi
E
E
Department of Pediatrics, Unit of Allergy and Respiratory Medicine, University of Padova, Padova, Italy.
Boner
A L
AL
Department of Pediatrics, University of Verona, Verona, Italy.
Cutrera
R
R
Respiratory Unit, Department of Pediatrics, Ospedale Pediatrico Bambino Gesù, Rome, Italy.
Rossi
G A
GA
Department of Pediatrics, Ospedale Gaslini, Genova, Italy.
Fabbri
L M
LM
Department of Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy.
Department of Respiratory Diseases, Research Center on Asthma and COPD, University of Ferrara, Ferrara, Italy.
D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D012135:Respiratory Sounds / Q000187:drug effects*; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D001507:Beclomethasone; D000420:Albuterol