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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-02-28

Brief Summary

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

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Detailed Description

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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 once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

mometasone

Group Type ACTIVE_COMPARATOR

Comparator: mometasone

Intervention Type DRUG

mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)

2

montelukast followed by placebo; or placebo followed by montelukast.

Group Type PLACEBO_COMPARATOR

Comparator: montelukast

Intervention Type DRUG

montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)

Comparator: placebo (unspecified)

Intervention Type DRUG

Placebo (Placebo once-daily, for approximately 2 weeks)

Interventions

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Comparator: mometasone

mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)

Intervention Type DRUG

Comparator: montelukast

montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)

Intervention Type DRUG

Comparator: placebo (unspecified)

Placebo (Placebo once-daily, for approximately 2 weeks)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No