Phase 4
N=445
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00832455 ↗Enrolled (actual)
445
Serious AEs
—
Results posted
Feb 2010
Primary outcome: Primary: Asthma Control Questionnaire (ACQ) — 328; 159; 96; 91 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- montelukast sodium (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control Questionnaire (ACQ) |
144; 60; 82; 208; 121; 216 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) |
144; 60; 82; 208; 121; 216 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00832455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.