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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00832455
First received: January 28, 2009
Last updated: November 13, 2013
Last verified: November 2013
Results First Received: August 25, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: montelukast sodium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First patient in: JUN-19-2006

Last patient out: OCT-28-2008

Total number of sites: 37 sites in Canada


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Montelukast Montelukast 4-5 mg for 12 weeks, oral tablet

Participant Flow:   Overall Study
    Montelukast  
STARTED     445 [1]
Baseline     420 [2]
Week 4     411  
Week 8 (Optional)     247  
Week 12     373  
COMPLETED     373  
NOT COMPLETED     72  
Adverse Event                 13  
Lost to Follow-up                 26  
Protocol Violation                 4  
Withdrawal by Subject                 17  
Screening Failure                 2  
Stopped Medication                 4  
Parent misunderstood study                 1  
Parent dissatisfied                 1  
No improvement                 3  
Patient moved                 1  
[1] 445 – number of patients that signed the informed consent form (Safety population)
[2] 420 –patients that received at least one dose of study medication and had 1 follow-up visit (ITT)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Montelukast Montelukast 4-5 mg for 12 weeks, oral tablet

Baseline Measures
    Montelukast  
Number of Participants  
[units: participants]
  420  
Age  
[units: years]
Mean ± Standard Deviation
  7.00  ± 3.33  
Gender  
[units: participants]
 
Female     168  
Male     252  
ICS (Inhaled Corticosteroids) Use  
[units: Participants]
 
Use     323  
No Use     97  
Asthma Diagnosis Duration  
[units: Months]
Mean ± Standard Deviation
  45.58  ± 34.72  



  Outcome Measures
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1.  Primary:   Asthma Control Questionnaire (ACQ)   [ Time Frame: Week 0, 4, and 12 ]

2.  Secondary:   Asthma Control Questionnaire (ACQ)   [ Time Frame: Week 0, 4, and 12 ]

3.  Other Pre-specified:   Physician Global Satisfaction   [ Time Frame: week 0, 4, 8 and 12 ]

4.  Other Pre-specified:   Patient Global Satisfaction   [ Time Frame: Week 0, 4, 8 and 12 ]

5.  Other Pre-specified:   Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)   [ Time Frame: Weeks 4, 8, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00832455     History of Changes
Other Study ID Numbers: 0476-385, MK0476-385, 2009_523
Study First Received: January 28, 2009
Results First Received: August 25, 2009
Last Updated: November 13, 2013
Health Authority: Canada: Health Canada