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

Asthma, Bronchial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092092
• Other study ID #: 0476-254
• Secondary ID: 2004_023
• Status: Completed
• Phase: Phase 4
• Start date: October 2002
• Est. completion date: June 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Drug:
• Montelukast chewable tablets
Montelukast sodium 5 mg chewable tablets
• Budesonide inhaler
Budesonide 200 mcg inhalation powder
• Placebo to montelukast chewable tablets
Placebo chewable tablets
• Placebo to budesonide inhaler
Placebo inhalation powder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term lower-leg growth rate (LLGR)	Lower leg length was measured in millimeters (mm) using a knemometer.	Baseline and Week 3