A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00140946
• Lead Sponsor: Organon and Co

Brief Summary

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 2000-10
• Study Completion: 2000-10
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

• Males or females between the ages of 18 and 70 with asthma

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of days of asthma exacerbations

Secondary Outcome Measures

Name	Time	Method
Percentage of nocturnal awakenings
Beta agonist use
Percentage of asthma free days