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Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00974571
First received: September 9, 2009
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
Results First Received: September 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: montelukast sodium
Drug: Comparator: cetirizine
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

74 study sites in the United States

Primary Therapy: Nov-2001 to May-2002

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.

Reporting Groups
  Description
Montelukast 10 mg Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
Cetirizine 10 mg Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
Placebo Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.

Participant Flow:   Overall Study
    Montelukast 10 mg     Cetirizine 10 mg     Placebo  
STARTED     630     122     613  
COMPLETED     562     106     530  
NOT COMPLETED     68     16     83  
Adverse Event                 31                 4                 27  
Lack of Efficacy                 3                 2                 9  
Lost to Follow-up                 2                 1                 2  
Protocol Violation                 13                 4                 18  
Withdrawal by Subject                 14                 5                 16  
Patient Moved                 1                 0                 1  
Unspecified                 4                 0                 10  



  Baseline Characteristics
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Reporting Groups
  Description
Montelukast 10 mg Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
Cetirizine 10 mg Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
Placebo Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Montelukast 10 mg     Cetirizine 10 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  630     122     613     1365  
Age  
[units: years]
Mean ± Standard Deviation 		  35.3  ± 12.87     36.3  ± 13.67     35.3  ± 13.17     35.4  ± 13.07  
Gender  
[units: participants]
 		       
Female     419     85     418     922  
Male     211     37     195     443  
Composite Symptoms score [1]
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.86  ± 0.44     1.89  ± 0.43     1.82  ± 0.45     1.85  ± 0.44  
Daytime Nasal Symptoms score [2]
[units: Scores on a scale]
Mean ± Standard Deviation 		  2.08  ± 0.40     2.13  ± 0.37     2.07  ± 0.40     2.08  ± 0.40  
Nighttime Symptoms score [3]
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.63  ± 0.62     1.65  ± 0.61     1.58  ± 0.62     1.61  ± 0.62  
[1] Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
[2] Patients were asked to rate each of 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptom scores was reported as the Daytime Nasal Symptoms Score.
[3] Patients were asked to rate each of 3 symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of the 3 symptoms was reported as the Nighttime Symptoms Score.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Daytime Nasal Symptoms Score   [ Time Frame: Baseline and first 4 weeks of a 6-week treatment period ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in Nighttime Symptoms Score   [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]
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3.  Secondary:   Mean Change From Baseline in Composite Symptoms Score   [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]
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4.  Secondary:   Patient's Global Evaluation of Allergic Rhinitis   [ Time Frame: End of the first 4 weeks in 6-week treatment period ]
  Show Outcome Measure 4

5.  Secondary:   Physician's Global Evaluation of Allergic Rhinitis   [ Time Frame: End of the first 4 weeks in 6-week treatment period ]
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Measure Type Secondary
Measure Title Physician's Global Evaluation of Allergic Rhinitis
Measure Description An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Time Frame End of the first 4 weeks in 6-week treatment period  
Safety Issue No  

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.
The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.

Reporting Groups
  Description
Montelukast 10 mg Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
Cetirizine 10 mg Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
Placebo Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.

Measured Values
    Montelukast 10 mg     Cetirizine 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  603     115     583  
Physician's Global Evaluation of Allergic Rhinitis  
[units: Scores on a scale]
Least Squares Mean ( 95% Confidence Interval ) 		  2.26  
  ( 2.16 to 2.36 )   		  2.20  
  ( 1.99 to 2.42 )   		  2.33  
  ( 2.23 to 2.43 )  

No statistical analysis provided for Physician's Global Evaluation of Allergic Rhinitis




  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


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00974571     History of Changes
Other Study ID Numbers: 2009_659, MK0476-246
Study First Received: September 9, 2009
Results First Received: September 17, 2009
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration