Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00832455
First received: January 28, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: montelukast sodium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Asthma Control Questionnaire (ACQ) [ Time Frame: Week 0, 4, and 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Asthma Control Questionnaire (ACQ) [ Time Frame: Week 0, 4, and 12 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 445
Study Start Date: June 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast Drug: montelukast sodium
Montelukast 4-5 mg for 12 weeks, oral tablet
Other Name: Singular

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832455

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00832455     History of Changes
Other Study ID Numbers: 2009_523, MK0476-385
Study First Received: January 28, 2009
Results First Received: August 25, 2009
Last Updated: April 21, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013