A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
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.
|Asthma, Bronchial||Drug: Montelukast sodium Drug: Placebo to montelukast Drug: Fluticasone propionate Drug: Placebo to fluticasone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma|
- Percentage of days without asthma [ Time Frame: 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) [ Time Frame: Up to 26 weeks ]
- Number of participants who discontinue study drug due to an AE [ Time Frame: Up to 24 weeks ]
- Percentage of days without daytime symptoms [ Time Frame: 24 weeks ]
- Percentage of days without nighttime cough [ Time Frame: 24 weeks ]
- Percentage of days without β-agonist use [ Time Frame: 24 weeks ]
- Percentage of participants without asthma attacks [ Time Frame: 24 weeks ]
- Percentage of participants without corticosteroid rescues [ Time Frame: 24 weeks ]
- Caregiver global evaluation [ Time Frame: Week 24 ]
- Physician global evaluation [ Time Frame: Week 24 ]
- Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation) [ Time Frame: 24 weeks ]
|Study Start Date:||November 2007|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Drug: Montelukast sodium
Montelukast 4 mg OG or montelukast 4 mg CT
Other Names:Drug: Placebo to fluticasone
Placebo inhalation aerosol metered dose inhaler
Active Comparator: Fluticasone
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.
Drug: Placebo to montelukast
Placebo OG or CTDrug: Fluticasone propionate
Fluticasone 50 mcg inhalation aerosol metered dose inhaler
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540839
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|