Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Patient Is Diagnosed With Asthma For At Least 6 Months

• Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)

• Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage

• Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion Criteria:

• As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)

• Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy