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Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337675
First received: June 14, 2006
Last updated: April 7, 2016
Last verified: April 2016
Results First Received: February 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: montelukast sodium
Drug: Comparator: Placebo (unspecified)

  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

Patients were recruited from 111 centers worldwide.

Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006.

The last patient's last visit was completed on 12-Aug-2009.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

1979 screened; 208 excluded.

Randomized patients met the following criteria: age 6-71 months, a history of episodic asthma symptoms that ranged between 2 and 6 episodes, depending on age, that were separated in time by periods without asthma symptoms. Patients had at least 1 corticosteroid treatment or were hospitalized for asthma at least 1 time.


Reporting Groups
  Description
Daily Montelukast Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Intermittent Montelukast Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Placebo Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

Participant Flow:   Overall Study
    Daily Montelukast   Intermittent Montelukast   Placebo
STARTED   589   591   591 
COMPLETED   492   488   492 
NOT COMPLETED   97   103   99 
Adverse Event                10                9                19 
Lack of Efficacy                10                7                9 
Lost to Follow-up                22                19                17 
Physician Decision                9                17                14 
Protocol Violation                21                24                19 
Withdrawal by Subject                25                25                19 
Progressive Disease                0                2                0 
Trial Terminated                0                0                2 



  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
Daily Montelukast Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Intermittent Montelukast Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Placebo Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Total Total of all reporting groups

Baseline Measures
   Daily Montelukast   Intermittent Montelukast   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 589   591   591   1771 
Age 
[Units: Months]
Mean (Full Range)
 39.0 
 (6.0 to 71.0) 
 39.5 
 (6.0 to 71.0) 
 39.3 
 (7.0 to 71.0) 
 39.2 
 (6.0 to 71.0) 
Gender 
[Units: Participants]
       
Female   239   226   238   703 
Male   350   365   353   1068 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period   [ Time Frame: 1-year treatment period ]

2.  Secondary:   Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode   [ Time Frame: 1 Year ]

3.  Secondary:   Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes   [ Time Frame: 1 Year ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00337675     History of Changes
Other Study ID Numbers: 0476-302
MK0476-302
2006_015
Study First Received: June 14, 2006
Results First Received: February 19, 2010
Last Updated: April 7, 2016
Health Authority: United States: Food and Drug Administration