Asthma diagnosis and treatmentComparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma
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.
References (21)
- et al.
Device selection and outcomes of aerosol therapy: evidence-based guidelines
Chest
(2005) - et al.
Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children
Ann Allergy Asthma Immunol
(1999) - et al.
Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma
J Allergy Clin Immunol
(1998) - et al.
Characterization of within-subject responses to fluticasone and montelukast in childhood asthma
J Allergy Clin Immunol
(2005) - et al.
Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma
J Pediatr
(2005) - et al.
Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial
J Allergy Clin Immunol
(2007) - et al.
Comparison of montelukast versus budesonide in the treatment of exercise-induced bronchoconstriction
Ann Allergy Asthma Immunol
(2001) - et al.
Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma
J Allergy Clin Immunol
(2006) - et al.
Secondary prevention of asthma by the use of Inhaled Fluticasone propionate in Wheezy INfants (IFWIN): double-blind, randomised, controlled study
Lancet
(2006) Expert panel report: guidelines for the diagnosis and management of asthma update on selected topics—2002
J Allergy Clin Immunol
(2002)
Cited by (0)
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.