Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972738
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : June 16, 2010
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: montelukast sodium
Drug: Comparator: loratadine
Drug: Comparator: Placebo
Enrollment 1214
Recruitment Details

Thirty-two study sites in Canada and the United States.

Primary Therapy Period: Apr-2001 to Jul-2001.

Pre-assignment Details Patients who required certain medications as described in the protocol 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.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Period Title: Overall Study
Started 522 171 521
Completed 501 165 492
Not Completed 21 6 29
Reason Not Completed
Adverse Event             7             1             8
Protocol Violation             2             1             3
Lost to Follow-up             1             0             1
Lack of Efficacy             5             1             11
Withdrawal by Subject             5             1             4
Moved             0             0             1
Other             1             2             1
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo Total
Hide Arm/Group Description Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 522 171 521 1214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
35.5  (13.93) 34.7  (12.73) 35.8  (12.61) 35.5  (13.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
Female
326
  62.5%
100
  58.5%
338
  64.9%
764
  62.9%
Male
196
  37.5%
71
  41.5%
183
  35.1%
450
  37.1%
Daytime Eye Symptoms score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
1.49  (0.77) 1.48  (0.79) 1.53  (0.81) 1.51  (0.79)
[1]
Measure Description: Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Daytime Nasal Symptoms score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
2.10  (0.43) 2.15  (0.45) 2.14  (0.43) 2.12  (0.43)
[1]
Measure Description: Patients were asked to rate each of the 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 symptoms scores was reported as the Daytime Nasal Symptoms Score.
Nighttime Symptoms score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
1.51  (0.65) 1.49  (0.64) 1.47  (0.65) 1.49  (0.65)
[1]
Measure Description: Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
Rhinoconjunctivitis Quality-of-Life score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 522 participants 171 participants 521 participants 1214 participants
3.22  (1.06) 3.24  (0.97) 3.29  (1.01) 3.25  (1.03)
[1]
Measure Description: Rhinoconjunctivitis Quality-of-Life score Description (see instructions; limit 350 characters) Self-administered questionnaire which included 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. Scores for each domain were average, then scores for the 7 domains were averaged for overall score.
1.Primary Outcome
Title Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
Hide Description Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 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 symptoms scores was reported as the Daytime Nasal Symptoms Score.
Time Frame Baseline and over the 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 519 170 521
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.38
(-0.43 to -0.33)
-0.47
(-0.55 to -0.39)
-0.29
(-0.33 to -0.24)
2.Secondary Outcome
Title Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
Hide Description Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
Time Frame Baseline and over the 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 519 170 521
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.28
(-0.32 to -0.24)
-0.28
(-0.35 to -0.21)
-0.20
(-0.25 to -0.16)
3.Secondary Outcome
Title Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
Hide Description Mean change from baseline in 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 [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Time Frame Baseline and over the 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 519 170 521
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.28
(-0.32 to -0.23)
-0.40
(-0.47 to -0.32)
-0.21
(-0.25 to -0.16)
4.Secondary Outcome
Title Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
Hide Description An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
Time Frame End of the 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 519 171 517
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
2.18
(2.05 to 2.31)
2.19
(1.97 to 2.42)
2.49
(2.36 to 2.62)
5.Secondary Outcome
Title Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
Hide Description An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
Time Frame End of the 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 521 171 515
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
2.18
(2.07 to 2.30)
2.16
(1.96 to 2.35)
2.41
(2.29 to 2.52)
6.Secondary Outcome
Title Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
Hide Description Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.
Time Frame Baseline and at the end of 2-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed.
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Number of Participants Analyzed 518 171 516
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.90
(-1.00 to -0.81)
-0.98
(-1.15 to -0.81)
-0.66
(-0.76 to -0.56)
Time Frame During the two week double-blind treatment period , and up to and including 14 days after the last dose of study therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast 10 mg Loratadine 10 mg Placebo
Hide Arm/Group Description Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
All-Cause Mortality
Montelukast 10 mg Loratadine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Montelukast 10 mg Loratadine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/522 (0.00%)   0/171 (0.00%)   0/521 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Montelukast 10 mg Loratadine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/522 (0.00%)   0/171 (0.00%)   0/521 (0.00%) 
In the paper patients who withdrew for worsening allergic rhinitis/conjunctivitis were included under category of discontinued due to lack of efficacy rather than discontinued due to clinical Adverse Events
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00972738    
Other Study ID Numbers: 0476-235
MK0476-235
2009_658
First Submitted: September 4, 2009
First Posted: September 7, 2009
Results First Submitted: September 15, 2009
Results First Posted: June 16, 2010
Last Update Posted: July 23, 2015