SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change of the asthma control questionnaire scores taken over 8 weeks
Eligibility
Minimum age: 15 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: March 6, 2007
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