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Montelukast Back to School Asthma Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00461032
First received: April 13, 2007
Last updated: May 12, 2010
Last verified: May 2010
History of Changes
Results First Received: January 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: montelukast
Drug: Comparator: Placebo

  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

Participants were randomized at 165 sites in the US and Canada.

Therapy period: June to November 2006 (including screening period).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.

Reporting Groups
  Description
Placebo Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
Montelukast 5 mg Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.

Participant Flow:   Overall Study
    Placebo     Montelukast 5 mg  
STARTED     582     580  
COMPLETED     545     536  
NOT COMPLETED     37     44  
Adverse Event                 5                 6  
Lack of Efficacy                 5                 1  
Lost to Follow-up                 7                 12  
Protocol Violation                 4                 4  
Withdrawal by Subject                 7                 15  
Patient Moved or Relocated                 2                 1  
Not Specified                 7                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
Montelukast 5 mg Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Montelukast 5 mg     Total  
Number of Participants  
[units: participants]
 		  582     580     1162  
Age  
[units: years]
Mean ± Standard Deviation 		  9.9  ± 2.5     9.9  ± 2.4     9.9  ± 2.5  
Gender  
[units: participants]
 		     
Female     236     225     461  
Male     346     355     701  
Daytime Asthma Symptom Score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.32  ± 1.81     1.35  ± 1.94     1.34  ± 1.88  
β-Agonist Use [2]
[units: puffs/day]
Mean ± Standard Deviation 		  0.62  ± 1.11     0.54  ± 0.94     0.58  ± 1.03  
[1] The Participant or parent/guardian scored his/her/child's symptoms [from 0 (best) to 5 (worst)] on a daily basis. Scores were entered into a Participant diary during the 2-week period prior to the start of the study drug.
[2] The number of puffs used per day was entered by the Participant or parent/guardian into a Participant diary during the 2-week period prior to the start of the study drug.



  Outcome Measures
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1.  Primary:   Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants   [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ]
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2.  Secondary:   Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)   [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants   [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants   [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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 by Merck

Publications automatically indexed to this study:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00461032     History of Changes
Other Study ID Numbers: 2007_539, MK0476-340
Study First Received: April 13, 2007
Results First Received: January 12, 2010
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration