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

NCT00832455 | Completed Phase 4 Results

• 3 other identifiers: 0476-385MK0476-3852009_523
• Study Type: interventional
• Target: 445
• Locations: 0 countries
• Sites: N/A

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire (ACQ)

  ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.

  Week 0, 4, and 12

Secondary Outcomes (1)

• Asthma Control Questionnaire (ACQ)

  Week 0, 4, and 12

Other Outcomes (3)

• Physician Global Satisfaction

  week 0, 4, 8 and 12

• Patient Global Satisfaction

  Week 0, 4, 8 and 12

• Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

  Weeks 4, 8, and 12

Study Arms (1)

Montelukast

EXPERIMENTAL

Drug: montelukast sodium

Interventions

montelukast sodium DRUG

Montelukast 4-5 mg for 12 weeks, oral tablet

Also known as: Singular

Montelukast

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Berube D, Djandji M, Sampalis JS, Becker A. Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study. Allergy Asthma Clin Immunol. 2014 May 6;10(1):21. doi: 10.1186/1710-1492-10-21. eCollection 2014.

  PMID: 24932181 RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Single Person

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 13, 2024
• Results First Posted: February 5, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share