Status:

COMPLETED

Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

Lead Sponsor:

Organon and Co

Conditions:

Asthma

Eligibility:

All Genders

2-5 years

Phase:

PHASE3

Brief Summary

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Eligibility Criteria

Inclusion

  • Patient has history of physician diagnosed asthma
  • Patient is in otherwise good stable health
  • Patient is able to chew a tablet

Exclusion

  • Patient is hospitalized
  • Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
  • Patient had any major surgical procedure within 4 weeks before the study
  • Patient had active sinus disease within 3 weeks before the study
  • Patient had required intubation for asthma in the past
  • Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
  • Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Key Trial Info

Start Date :

December 1 1997

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2001

Estimated Enrollment :

689 Patients enrolled

Trial Details

Trial ID

NCT00968201

Start Date

December 1 1997

End Date

March 1 2001

Last Update

February 3 2022

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