A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
- Conditions
- Asthma, Bronchial
- Interventions
- Registration Number
- NCT00540839
- Lead Sponsor
- Organon and Co
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Montelukast Montelukast sodium Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged \>6 months to \<2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive montelukast 4 mg CT QD for 24 weeks. Fluticasone Placebo to montelukast Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged \>6 months to \<2 years receive placebo packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive placebo CT QD for 24 weeks. Montelukast Placebo to fluticasone Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged \>6 months to \<2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive montelukast 4 mg CT QD for 24 weeks. Fluticasone Fluticasone propionate Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged \>6 months to \<2 years receive placebo packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive placebo CT QD for 24 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of days without daytime symptoms 24 weeks Percentage of days without nighttime cough 24 weeks Percentage of days without β-agonist use 24 weeks