Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma.
BACKGROUND
Budesonide inhalation suspension and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in young children are needed.


OBJECTIVE
To compare the long-term efficacy and safety of budesonide inhalation suspension and montelukast.


METHODS
After a run-in period, children 2 to 8 years old with mild asthma or recurrent wheezing were randomized to once-daily budesonide inhalation suspension 0.5 mg or once-daily oral montelukast 4 or 5 mg for 52 weeks. Subjects were stepped up to twice-daily budesonide inhalation suspension or oral corticosteroids for mild or severe asthma worsening, respectively. The primary outcome was time to first additional medication for asthma worsening at 52 weeks. Secondary variables included times to the first additional asthma medication measured at 12 and 26 weeks; times to the first asthma exacerbation (mild and severe) measured at 12, 26, and 52 weeks; exacerbation rates (mild and severe) over a period of 52 weeks; diary variables (eg, peak expiratory flow [PEF]); patient-reported outcomes; and Global Physician and Caregiver Assessments.


RESULTS
No significant between-group differences were observed for time to first additional asthma medication at 52 weeks; however, time to first additional asthma medication was longer (unadjusted P = .050) at 12 weeks and exacerbation rates were lower over a period of 52 weeks (unadjusted P = .034) for budesonide versus montelukast. Time to first severe exacerbation (requiring oral corticosteroids) was similar in both groups, but the percentage of subjects requiring oral corticosteroids over a period of 52 weeks was lower with budesonide (25.5% vs 32.0%). Peak flow and Caregiver and Physician Global Assessments favored budesonide.


CONCLUSIONS
Both treatments provided acceptable asthma control; however, overall measures favored budesonide inhalation suspension over montelukast.


CONCLUSIONS
These findings are consistent with studies in older children demonstrating better outcomes with inhaled corticosteroids versus montelukast.
Szefler
Stanley J
SJ
Division of Pediatric Clinical Pharmacology and Allergy/Immunology, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206, USA. szeflers@njc.org
Baker
James W
JW
Uryniak
Tom
T
Goldman
Mitchell
M
Silkoff
Philip E
PE
D000085:Acetates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000280:Administration, Inhalation; D000367:Age Factors; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast