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

Asthma, Bronchial Clinical Trial

Official title:

A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00540839
• Other study ID #: 0476-303
• Secondary ID: 2007_583
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2007

Study information

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

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Drug:
• Montelukast sodium
Montelukast 4 mg OG or montelukast 4 mg CT
• Placebo to montelukast
Placebo OG or CT
• Fluticasone propionate
Fluticasone 50 mcg inhalation aerosol metered dose inhaler
• Placebo to fluticasone
Placebo inhalation aerosol metered dose inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participants without asthma attacks		24 weeks
Other	Percentage of participants without corticosteroid rescues		24 weeks
Other	Caregiver global evaluation		Week 24
Other	Physician global evaluation		Week 24
Other	Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation)		24 weeks
Primary	Percentage of days without asthma	A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no ß-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor], or treatment with systemic corticosteroid during the previous 24 hours).	24 weeks
Primary	Number of participants who experience at least one adverse event (AE)		Up to 26 weeks
Primary	Number of participants who discontinue study drug due to an AE		Up to 24 weeks
Secondary	Percentage of days without daytime symptoms		24 weeks
Secondary	Percentage of days without nighttime cough		24 weeks
Secondary	Percentage of days without ß-agonist use		24 weeks