Asthma diagnosis and treatment
Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma

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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.

Conclusion

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

Clinical implications

These findings are consistent with studies in older children demonstrating better outcomes with inhaled corticosteroids versus montelukast.

Section snippets

Subjects

Children 2 to 8 years of age were eligible for the study if they had symptoms of mild persistent asthma as determined by 2002 NAEPP guidelines1 or had, in the year before screening, a history of ≥3 wheezing episodes that lasted >1 day and affected sleep. In addition, to be eligible for randomization, subjects were required to have a cumulative asthma symptom score (daytime plus nighttime) of ≥2 on ≥3 of 7 consecutive days and must have required the use of β2-adrenergic agonists on ≥3 of 7

Subjects

Of 645 subjects screened, 395 were randomized at 55 centers in the United States between October 16, 2002, and February 2, 2005, to receive BIS (n = 197) or montelukast (n = 198). One hundred fifteen subjects (29.1%) did not complete the study (Fig 2; see this article's Online Repository at www.jacionline.org). Subject demographics were similar in both treatment groups (Table I; see this article's Table E1 in the Online Repository at www.jacionline.org). Subjects in both treatment groups were

Discussion

The results of this study demonstrated that both BIS and montelukast were efficacious and well tolerated in this group of children with mild asthma or recurrent wheezing, with no new safety findings or concerns identified. No significant differences were observed between the BIS and montelukast groups on the primary efficacy variable, time to first additional asthma medication with either step-up BIS for mild asthma exacerbations or oral corticosteroid for severe exacerbations at 52 weeks.

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Supported by AstraZeneca LP.

Disclosure of potential conflict of interest: S. J. Szefler has consulting arrangements with AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck and has received grant support from the National Institutes of Health, the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, and Ross Pharmaceuticals. J. W. Baker has received grant support from GlaxoSmithKline, AstraZeneca, Apieron, NIOXX, Sanofi-Aventis, Amgen, ALK, Altana, MedPointe, Centocor, IVAX, JNJ, and Wyeth and is on the speakers' bureau for AstraZeneca, Novartis, and Merck. T. Uryniak, M. Goldman, and P. E. Silkoff own stock in and are employed by AstraZeneca.

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