We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832455
First Posted: January 30, 2009
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
January 28, 2009
January 30, 2009
August 25, 2009
February 5, 2010
April 10, 2017
June 2006
October 2008   (Final data collection date for primary outcome measure)
Asthma Control Questionnaire (ACQ) [ Time Frame: Week 0, 4, and 12 ]
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.
To describe the percentage of patients with asthma who will be controlled after 4 and 12 weeks of treatment with montelukast as monotherapy or in combination with inhaled corticosteroids [ Time Frame: 4 and 12 weeks after treatment ]
Complete list of historical versions of study NCT00832455 on ClinicalTrials.gov Archive Site
Asthma Control Questionnaire (ACQ) [ Time Frame: Week 0, 4, and 12 ]
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.
To describe the percentage of patients who will be able to taper their inhaled corticosteroids therapy after 4, 8 and 12 weeks of treatment with montelukast and maintain control of their asthma [ Time Frame: 4, 8 and 12 weeks ]
  • Physician Global Satisfaction [ Time Frame: week 0, 4, 8 and 12 ]
    At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.
  • Patient Global Satisfaction [ Time Frame: Week 0, 4, 8 and 12 ]
    At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
  • Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: Weeks 4, 8, and 12 ]

    The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ).

    PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described.

Not Provided
 
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma
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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Drug: montelukast sodium
Montelukast 4-5 mg for 12 weeks, oral tablet
Other Name: Singular
Experimental: Montelukast
Intervention: Drug: montelukast sodium
Bérubé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
445
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00832455
0476-385
MK0476-385
2009_523
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP