Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092092
First received: September 21, 2004
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.


Condition Intervention Phase
Asthma, Bronchial
Drug: Montelukast chewable tablets
Drug: Budesonide inhaler
Drug: Placebo to montelukast chewable tablets
Drug: Placebo to budesonide inhaler
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Short-term lower-leg growth rate (LLGR) [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    Lower leg length was measured in millimeters (mm) using a knemometer.


Enrollment: 71
Study Start Date: October 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast→Placebo
Participants receive one montelukast 5 mg chewable tablet once daily (QD) for 3 weeks. After a 2-week washout period, participants receive one placebo chewable tablet QD for 3 weeks.
Drug: Montelukast chewable tablets
Montelukast sodium 5 mg chewable tablets
Drug: Placebo to montelukast chewable tablets
Placebo chewable tablets
Experimental: Placebo→Montelukast
Participants receive one placebo chewable tablet QD for 3 weeks. After a 2-week washout period, participants receive one montelukast 5 mg chewable tablet QD for 3 weeks.
Drug: Montelukast chewable tablets
Montelukast sodium 5 mg chewable tablets
Drug: Placebo to montelukast chewable tablets
Placebo chewable tablets
Active Comparator: Budesonide→Placebo
Participants receive budesonide 200 mcg inhalation powder twice daily (BID) for 3 weeks. After a 2-week washout period, participants receive placebo inhalation powder BID for 3 weeks.
Drug: Budesonide inhaler
Budesonide 200 mcg inhalation powder
Drug: Placebo to budesonide inhaler
Placebo inhalation powder
Active Comparator: Placebo→Budesonide
Participants receive placebo inhalation powder BID for 3 weeks. After a 2-week washout period, participants receive budesonide 200 mcg inhalation powder BID for 3 weeks.
Drug: Budesonide inhaler
Budesonide 200 mcg inhalation powder
Drug: Placebo to budesonide inhaler
Placebo inhalation powder

Detailed Description:

This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A 6-month history of asthma with periodic episodes requiring treatment.

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
  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: NCT00092092

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092092     History of Changes
Other Study ID Numbers: 0476-254, 2004_023
Study First Received: September 21, 2004
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014