Status:
COMPLETED
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
2-14 years
Phase:
PHASE4
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00832455
Start Date
June 1 2006
End Date
October 1 2008
Last Update
May 13 2024
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