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

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00666679
• Lead Sponsor: Organon and Co

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 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 Timeline

• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Study Start: 2008-05
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-01-07
• Results First Submitted QC: 2010-01-07
• Results First Posted: 2010-02-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Name	Time	Method
Change From Baseline in Daytime Asthma Symptom Score	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.
Change From Baseline in Nighttime Asthma Symptom Score	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.