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Clinical Trials/NCT00140946
NCT00140946
Completed
Phase 4

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

Organon and Co0 sites546 target enrollmentMarch 1998

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Asthma
Sponsor
Organon and Co
Enrollment
546
Primary Endpoint
Percentage of days of asthma exacerbations
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Registry
clinicaltrials.gov
Start Date
March 1998
End Date
October 2000
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males or females between the ages of 18 and 70 with asthma

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of days of asthma exacerbations

Secondary Outcomes

  • Percentage of asthma free days
  • Percentage of nocturnal awakenings
  • Beta agonist use

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