The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384) (SAS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients Is 18 Years Old
Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit
Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained
Exclusion criteria
- Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
800 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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