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

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832455

0476-385

MK0476-385

2009_523

Details and patient eligibility

About

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

Enrollment: 445 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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445 participants in 1 patient group

Montelukast

Experimental group

Treatment:

Drug: montelukast sodium