SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

NCT ID: NCT00445107

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-01
• Study Completion Date: 2006-05-17

Brief Summary

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK0476, montelukast sodium / Duration of Treatment: 8 Weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
• Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

Exclusion Criteria

• Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
• Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
• Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_002

Identifier Type: -

Identifier Source: secondary_id

0476-363

Identifier Type: -

Identifier Source: org_study_id