A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

Organon

Status and phase: Withdrawn; Phase 3

Conditions: Asthma, Bronchial

Treatments: Drug: Placebo to fluticasone; Drug: Fluticasone propionate; Drug: Placebo to montelukast; Drug: Montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540839

0476-303

2007_583 (Other Identifier)

Details and patient eligibility

About

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.

This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Full description

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 6 months and 5 years, 4 months of age
• Diagnosed with asthma by a doctor
• At least 3 episodes of asthma symptoms within the last 6 months

Exclusion criteria

• Active or chronic breathing disease, other than asthma
• Required insertion of a breathing tube for asthma
• Major surgery within the last 4 weeks
• Currently in the hospital
• Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups

Montelukast

Experimental group

Description:

Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged \>6 months to \<2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive montelukast 4 mg CT QD for 24 weeks.

Treatment:

Drug: Montelukast sodium

Drug: Placebo to fluticasone

Fluticasone

Active Comparator group

Description:

Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged \>6 months to \<2 years receive placebo packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive placebo CT QD for 24 weeks.

Treatment:

Drug: Fluticasone propionate

Drug: Placebo to montelukast