Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study

• Mean Change From Baseline in Nighttime Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  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.
• Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  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)).
• Mean Change From Baseline in Daytime Eye Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  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.
• Mean Change From Baseline in Daytime Nasal Congestion Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
• Mean Change From Baseline in Daytime Rhinorrhea Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
• Mean Change From Baseline in Daytime Nasal Itching Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
• Mean Change From Baseline in Daytime Sneezing Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
• Mean Change From Baseline in Nasal Congestion Upon Awakening [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
• Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  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).
• Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  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).
• Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  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.

• Mean change from baseline in Nighttime Symptoms Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Composite Symptoms score (Daytime Nasal and Nighttime Symptoms) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Daytime Eye Symptoms Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Daytime Nasal Congestion score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Daytime Rhinorrhea score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Daytime Nasal Itching score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Daytime Sneezing score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Nasal Congestion Upon Awakening [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in Rhinoconjunctivitis Quality-of-Life Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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.

• Drug: Comparator: montelukast/loratadine
  montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
• Drug: Comparator: montelukast
  montelukast 10 mg tablet taken once daily at bed time for 2 weeks
• Drug: Comparator: loratadine
  loratadine 10 mg tablet taken once daily at bed time for 2 weeks
• Drug: Comparator: placebo
  placebo tablet taken once daily at bed time for 2 weeks

• Experimental: 1
  montelukast/loratadine
  Intervention: Drug: Comparator: montelukast/loratadine
• Experimental: 2
  loratadine
  Intervention: Drug: Comparator: loratadine
• Experimental: 3
  montelukast
  Intervention: Drug: Comparator: montelukast
• Placebo Comparator: 4
  placebo
  Intervention: Drug: Comparator: placebo

Inclusion Criteria:

• Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
• Patient is a nonsmoker
• Patient is in good general health

Exclusion Criteria:

• Patient is hospitalized
• Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
• Patient intends to move or vacation away during the study
• Patient has had any major surgery within 4 weeks of study start
• Patient is a current or past abuser of alcohol or illicit drugs
• Patient has been treated in an emergency room for asthma in the past month
• Patient had an upper respiratory infection with in 3 weeks prior to study start
• Patient has any active pulmonary disorder other than asthma