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Clinical Trials/NCT00092144
NCT00092144
Completed
Phase 3

A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season

Organon and Co0 sites500 target enrollmentFebruary 26, 2004
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ConditionsAsthma
DrugsMK0476, montelukast sodium / Duration of Treatment: 4 weeksComparator: placebo / Duration of Treatment: 4 weeks

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Asthma
Sponsor
Organon and Co
Enrollment
500
Primary Endpoint
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Registry
clinicaltrials.gov
Start Date
February 26, 2004
End Date
June 15, 2004
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Asthma symptoms brought on by allergies

Exclusion Criteria

  • •Patient has any lung disease
  • •Currently have a sinus infection or cold symptoms

Outcomes

Primary Outcomes

To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcomes

  • To assess the following over a 3-week treatment period:
  • nighttime symptoms
  • AM PEFR
  • B-agonist use
  • PM PEFR
  • discontinuations due to asthma
  • asthma attacks

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