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

Organon and Co134 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Asthma

Interventions

Comparator: mometasoneDRUG

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

Comparator: montelukastDRUG

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

Comparator: placebo (unspecified)DRUG

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

Time frame: Baseline and 2 weeks

Secondary Outcomes

Change From Baseline in Daytime Asthma Symptom Score

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 \[best\] to 6 \[worst\]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

Time frame: Baseline and 2 weeks

Change From Baseline in Nighttime Asthma Symptom Score

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 \[best\] to 3 \[worst\]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

Time frame: Baseline and 2 weeks

Data from ClinicalTrials.gov

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