A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

This study has been withdrawn prior to enrollment.
(Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00540839
First received: October 4, 2007
Last updated: June 30, 2014
Last verified: June 2014

October 4, 2007
June 30, 2014
November 2007
March 2008   (final data collection date for primary outcome measure)
  • Percentage of days without asthma [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinue study drug due to an AE [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00540839 on ClinicalTrials.gov Archive Site
  • Percentage of days without daytime symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of days without nighttime cough [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of days without β-agonist use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment. [ Time Frame: 24 weeks ]
  • Percentage of participants without asthma attacks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants without corticosteroid rescues [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Caregiver global evaluation [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Physician global evaluation [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
 
A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
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

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.

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asthma, Bronchial
  • Drug: Montelukast sodium
    Montelukast 4 mg OG or montelukast 4 mg CT
    Other Names:
    • MK-0476
    • Singulair®
  • Drug: Placebo to montelukast
    Placebo OG or CT
  • Drug: Fluticasone propionate
    Fluticasone 50 mcg inhalation aerosol metered dose inhaler
  • Drug: Placebo to fluticasone
    Placebo inhalation aerosol metered dose inhaler
  • Experimental: Montelukast
    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.
    Interventions:
    • Drug: Montelukast sodium
    • Drug: Placebo to fluticasone
  • 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.
    Interventions:
    • Drug: Placebo to montelukast
    • Drug: Fluticasone propionate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
March 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00540839
0476-303, 2007_583
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP