Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Asthma Clinical Trial

Official title:

A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943397
• Other study ID #: 0476-232
• Secondary ID: MK0476-2322009_6
• Status: Completed
• Phase: Phase 3
• Start date: April 2001
• Est. completion date: November 2001

Study information

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

Clinical Trial Summary

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

Inclusion Criteria:

• Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)

OR:

• Patient is in good, stable health

• Patient has been fed solid foods for at least 1 month

• Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit

• Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

• Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior

• Patient had an allergy to apples or applesauce

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
• Comparator: Usual Care
Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.210 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	Up to 52 weeks of treatment