This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
907
montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
montelukast 10 mg tablet taken once daily at bed time for 2 weeks
loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Mean Change From Baseline in Daytime Nasal Symptoms Score
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 Week 2
Mean Change From Baseline in Nighttime Symptoms Score
Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), 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 Week 2
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
Mean Change From Baseline in Daytime Eye Symptoms Score
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 (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 Week 2
Mean Change From Baseline in Daytime Nasal Congestion Score
Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placebo tablet taken once daily at bed time for 2 weeks
Mean Change From Baseline in Daytime Rhinorrhea Score
Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
Mean Change From Baseline in Daytime Nasal Itching Score
Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
Mean Change From Baseline in Daytime Sneezing Score
Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
Mean Change From Baseline in Nasal Congestion Upon Awakening
Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
Time frame: Baseline and Week 2
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Time frame: Week 2
Physician's Global Evaluation of Allergic Rhinitis
An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Time frame: Week 2
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale \[0(best) to 6(worst)\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.
Time frame: Week 2