Linear Growth Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00395408

Purpose

The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.

Condition	Intervention	Phase
Asthma	Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups

Secondary Outcome Measures:

To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
Beta-agonist use
Oral corticosteroid rescues for asthma
Discontinuations due to asthma
Peripheral blood eosinophil count
Markers of bone turn-over

Estimated Enrollment:	300
Study Start Date:	June 2000

Eligibility

Ages Eligible for Study:	6 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria :

Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)

Exclusion Criteria :

Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395408

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7.

ClinicalTrials.gov Identifier:	NCT00395408 History of Changes
Other Study ID Numbers:	2006_550
Study First Received:	November 1, 2006
Last Updated:	January 10, 2007
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
Beclomethasone
Montelukast

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 12, 2012