Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00284856
First received: January 31, 2006
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: April 6, 2011  
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 sodium
Drug: Comparator: Placebo
Drug: Comparator: fluticasone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1640 participants enrolled in the study, 621 participants were excluded during screening and not randomized. The remaining 1019 participants were randomized.

Reporting Groups
  Description
Montelukast Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Fluticasone Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
Placebo Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months

Participant Flow:   Overall Study
    Montelukast     Fluticasone     Placebo  
STARTED     347     336     336  
COMPLETED     296     286     276  
NOT COMPLETED     51     50     60  
Adverse Event                 3                 3                 3  
Lack of Efficacy                 2                 1                 8  
Lost to Follow-up                 25                 21                 22  
Protocol Violation                 5                 4                 5  
Withdrawal by Subject                 12                 16                 18  
Unspecified                 4                 5                 4  



  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 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Fluticasone Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
Placebo Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Total Total of all reporting groups

Baseline Measures
    Montelukast     Fluticasone     Placebo     Total  
Number of Participants  
[units: participants]
  347     336     336     1019  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 10.4     38.4  ± 10.7     37.9  ± 9.9     38.0  ± 10.3  
Gender  
[units: participants]
       
Female     163     147     166     476  
Male     184     189     170     543  



  Outcome Measures
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1.  Primary:   Percentage of Asthma-control Days Over the 6-month Treatment Period   [ Time Frame: 6 months ]

2.  Secondary:   Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00284856     History of Changes
Other Study ID Numbers: 0476-332, 2005_108
Study First Received: January 31, 2006
Results First Received: April 6, 2011
Last Updated: March 6, 2014
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs