Overview

The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

Status:
Completed

Trial end date:
2007-09-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Treatments:

Montelukast

Criteria

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