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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