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Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00963469
First received: August 19, 2009
Last updated: May 12, 2010
Last verified: May 2010
History of Changes
Results First Received: September 16, 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: Seasonal Allergic Rhinitis
Interventions: Drug: montelukast sodium
Drug: Comparator: loratadine
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

Forty-seven study centers in the United States.

Prime Therapy Period: August 2001 to November 2001

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 nasal symptoms score during the run-in period were excluded from randomization.

Reporting Groups
  Description
Placebo Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks

Participant Flow:   Overall Study
    Placebo     Montelukast     Loratadine  
STARTED     451     448     180  
COMPLETED     410     420     170  
NOT COMPLETED     41     28     10  
Adverse Event                 15                 11                 1  
Lack of Efficacy                 10                 7                 2  
Lost to Follow-up                 1                 1                 0  
Protocol Violation                 5                 5                 3  
Withdrawal by Subject                 4                 1                 1  
Pre-randomization Adverse Event                 1                 2                 0  
Moved                 1                 0                 0  
Site closed (local pollen Season ended)                 4                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Montelukast     Loratadine     Total  
Number of Participants  
[units: participants]
 		  451     448     180     1079  
Age  
[units: years]
Mean ( Full Range ) 		  35.9  
  ( 15 to 82 )   		  35.5  
  ( 15 to 82 )   		  38.7  
  ( 15 to 79 )   		  36.2  
  ( 15 to 82 )  
Gender  
[units: participants]
 		       
Female     301     301     119     721  
Male     150     147     61     358  
Composite Symptoms Score [1]
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.94  ± 0.46     1.98  ± 0.47     2.03  ± 0.46     1.97  ± 0.46  
Daytime Eye Symptoms score [2]
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.61  ± 0.81     1.64  ± 0.73     1.64  ± 0.78     1.63  ± 0.77  
Daytime Nasal Symptoms Score [3]
[units: Scores on a scale]
Mean ± Standard Deviation 		  2.16  ± 0.44     2.20  ± 0.46     2.23  ± 0.44     2.19  ± 0.45  
Nighttime Symptoms Score [4]
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.65  ± 0.64     1.69  ± 0.64     1.77  ± 0.63     1.69  ± 0.64  
Rhinoconjunctivitis Quality of Life Score [5]
[units: Scores on a scale]
Mean ± Standard Deviation 		  3.37  ± 1.02     3.41  ± 1.00     3.46  ± 1.08     3.40  ± 1.02  
[1] Composite Symptoms Scores were computed as the average of Daytime Nasal Scores (Score 0 (best) to 3 (worst)) and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
[2]

Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)].

The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
[3]

Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worse)].

The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
[4] Nighttime Symptoms Score. Patients were asked to rate each symptom of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the average score of the 3 symptoms was reported as the Nighttime Symptoms Score.
[5] Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period   [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period   [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period   [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period   [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ]
  Show Outcome Measure 4

5.  Secondary:   Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment   [ Time Frame: After first 2 weeks of treatment ]
  Show Outcome Measure 5

6.  Secondary:   Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment   [ Time Frame: After first 2 weeks of treatment ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
Measure Description An evaluation by the physician, administered after the first 2 weeks of treatment 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 After first 2 weeks of treatment  
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. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.

Reporting Groups
  Description
Placebo Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks

Measured Values
    Placebo     Montelukast     Loratadine  
Number of Participants Analyzed  
[units: participants]
 		  434     424     172  
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment  
[units: Scores on a scale]
Least Squares Mean ( 95% Confidence Interval ) 		  2.75  
  ( 2.62 to 2.88 )   		  2.36  
  ( 2.23 to 2.50 )   		  2.38  
  ( 2.18 to 2.59 )  

No statistical analysis provided for Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment



7.  Secondary:   Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period   [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ]
  Show Outcome Measure 7


  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


Publications:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00963469     History of Changes
Other Study ID Numbers: 2009_647, MK0476-240
Study First Received: August 19, 2009
Results First Received: September 16, 2009
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration