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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Asthma, Bronchial
Drug: Montelukast sodium
Drug: Placebo to montelukast
Drug: Fluticasone propionate
Drug: Placebo to fluticasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: November 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Montelukast sodium
Montelukast 4 mg OG or montelukast 4 mg CT
Other Names:
  • MK-0476
  • Singulair®
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 CT
Drug: Fluticasone propionate
Fluticasone 50 mcg inhalation aerosol metered dose inhaler

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540839

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00540839     History of Changes
Other Study ID Numbers: 0476-303, 2007_583
Study First Received: October 4, 2007
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Montelukast
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014