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Completed

NCT Number: NCT00666679

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: mometasone

Drug

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

Comparator: montelukast

Drug

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

Comparator: Placebo (Unspecified)

Drug

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

Primary outcomes

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

    Time frame: Baseline and 2 weeks

    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.

Secondary outcomes

  1. Change From Baseline in Daytime Asthma Symptom Score

    Time frame: Baseline and 2 weeks

    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.

  2. Change From Baseline in Nighttime Asthma Symptom Score

    Time frame: Baseline and 2 weeks

    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.

Other outcomes

  1. Change From Baseline in Total Daily β-agonist Use

    Time frame: Baseline and 2 weeks

    To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

  2. Percentage of Days With Asthma Control

    Time frame: 2 weeks

    To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

  3. Percentage of Days With Asthma Exacerbations

    Time frame: 2 Weeks

    To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.

  4. Change From Baseline in Total Peripheral Blood Eosinophils

    Time frame: Baseline and 2 weeks

    To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 25, 2008
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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