This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,079
montelukast 10 mg tablet orally once daily in the morning for 4 weeks
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
placebo tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
Mean change from baseline in 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.
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worse)\], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \[Score 0 (best) to 3 (worst)\] and Nighttime Symptoms Scores \[Score 0 (best) to 3 (worst)\].
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom 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.
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
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Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
An evaluation by the patient, 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
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
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
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
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.
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)