This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,214
Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
placebo tablet orally once daily at bedtime for 2 weeks
Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
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
Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
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
Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
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
Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
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
Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
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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
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
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