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

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma, Bronchial

Treatments: Drug: Placebo to budesonide inhaler; Drug: Placebo to montelukast chewable tablets; Drug: Budesonide inhaler; Drug: Montelukast chewable tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092092

2004_023 (Other Identifier)

0476-254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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71 participants in 4 patient groups

Montelukast→Placebo

Experimental group

Description:

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.

Treatment:

Drug: Montelukast chewable tablets

Drug: Placebo to montelukast chewable tablets

Placebo→Montelukast

Experimental group

Description:

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.

Treatment:

Drug: Montelukast chewable tablets

Drug: Placebo to montelukast chewable tablets

Budesonide→Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Budesonide inhaler

Drug: Placebo to budesonide inhaler

Placebo→Budesonide

Active Comparator group

Description:

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.

Treatment:

Drug: Budesonide inhaler

Drug: Placebo to budesonide inhaler