Status:

COMPLETED

Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)

Lead Sponsor:

Organon and Co

Conditions:

Asthma

Eligibility:

All Genders

15-85 years

Phase:

PHASE2

Brief Summary

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed Description

During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg on...

Eligibility Criteria

Inclusion

  • Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
  • Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator

Exclusion

  • Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
  • Has required an oral corticosteroid rescue for worsening asthma during the screening period

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2009

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT00666679

Start Date

May 1 2008

End Date

February 1 2009

Last Update

May 10 2024

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