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Completed

NCT Number: NCT00395408

Linear Growth Study (0476-097)(COMPLETED)

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0476, montelukast sodium / Duration of Treatment : 56 Weeks

Drug

Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks

Drug

Primary outcomes

  1. 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 outcomes

  1. To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1

  2. Beta-agonist use

  3. Oral corticosteroid rescues for asthma

  4. Discontinuations due to asthma

  5. Peripheral blood eosinophil count

  6. Markers of bone turn-over

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Nov 2, 2006
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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