NCT00666679

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Comparator: mometasone	mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
DRUG	Comparator: montelukast	montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
DRUG	Comparator: placebo (unspecified)	Placebo (Placebo once-daily, for approximately 2 weeks)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-04-25
• Last updated: 2024-05-10
• Results posted: 2010-02-03