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NCT00445107 Clinical Trial

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

Asthma Clinical Trial

— STAR  

Official title:
An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00445107
Other study ID # 0476-363
Secondary ID 2007_002
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1, 2005
Est. completion date May 17, 2006

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date May 17, 2006
Est. primary completion date May 1, 2006
Accepts healthy volunteers No
Gender All
Age group 15 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment: 8 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Change of the asthma control questionnaire scores taken over 8 weeks
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