Asthma
Conditions
Brief summary
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.
Interventions
DRUGMK0476, montelukast sodium / Duration of Treatment : 56 Weeks
DRUGComparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
: * Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty) * Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty * With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)
Exclusion criteria
: * Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Beta-agonist use | — |
| Oral corticosteroid rescues for asthma | — |
| To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1 | — |
| Peripheral blood eosinophil count | — |
| Markers of bone turn-over | — |
| Discontinuations due to asthma | — |
Outcome results
None listed