Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

Organon

Status and phase: Completed; Phase 3

Conditions: Exercise Induced Asthma

Treatments: Drug: Salmeterol matching placebo; Drug: Montelukast matching placebo; Drug: Salmeterol xinafoate; Drug: Montelukast sodium; Drug: Fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127166

0476-911

2004_006 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.

Enrollment: 154 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-14 year old children with a history of asthma for at least 12 months
• must demonstrate airway constriction brought on by exercise

Exclusion criteria

• is taking any medications that are not allowed in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Montelukast/Salmeterol

Experimental group

Description:

Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

Treatment:

Drug: Salmeterol matching placebo

Drug: Montelukast matching placebo

Drug: Salmeterol xinafoate

Drug: Montelukast sodium

Drug: Fluticasone propionate

Salmeterol/Montelukast

Experimental group

Description:

Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

Treatment:

Drug: Salmeterol matching placebo

Drug: Montelukast matching placebo

Drug: Salmeterol xinafoate

Drug: Montelukast sodium

Drug: Fluticasone propionate