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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

NCT00755794

Asthma

COMPLETED PHASE3

Evaluation Montelukast in the Treatment of Status Asthmaticus

NCT01770899

Status Asthmaticus

UNKNOWN NA

Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

NCT00213252

Asthma, Bronchial

COMPLETED PHASE2

Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

NCT00289874

Asthma

COMPLETED PHASE3

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

NCT00641472

Asthma

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Montelukast

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

Montelukast 4-5 mg for 12 weeks, oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

montelukast sodium

Montelukast 4-5 mg for 12 weeks, oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Singular

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No