Asthma, Bronchial
Conditions
Brief summary
A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
Detailed description
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
Interventions
DRUGMontelukast sodium
Montelukast 4 mg OG or montelukast 4 mg CT
Placebo OG or CT
DRUGFluticasone propionate
Fluticasone 50 mcg inhalation aerosol metered dose inhaler
DRUGPlacebo to fluticasone
Placebo inhalation aerosol metered dose inhaler
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Between 6 months and 5 years, 4 months of age * Diagnosed with asthma by a doctor * At least 3 episodes of asthma symptoms within the last 6 months
Exclusion criteria
* Active or chronic breathing disease, other than asthma * Required insertion of a breathing tube for asthma * Major surgery within the last 4 weeks * Currently in the hospital * Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of days without asthma | 24 weeks | A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma \[other than a scheduled visit to a doctor\], or treatment with systemic corticosteroid during the previous 24 hours). |
| Number of participants who experience at least one adverse event (AE) | Up to 26 weeks | — |
| Number of participants who discontinue study drug due to an AE | Up to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of days without β-agonist use | 24 weeks |
| Percentage of days without daytime symptoms | 24 weeks |
| Percentage of days without nighttime cough | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| Physician global evaluation | Week 24 |
| Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation) | 24 weeks |
| Percentage of participants without asthma attacks | 24 weeks |
| Percentage of participants without corticosteroid rescues | 24 weeks |
| Caregiver global evaluation | Week 24 |
Outcome results
None listed