Clinical trial NCT00963469: Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 1079
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient has a history of seasonal allergic rhinitis that worsens during the study season
* Patient is a nonsmoker
* Patient is in good health physical and mental health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \< 8 weeks postpartum or is breastfeeding
* Patient plans to move or vacation away during the study
* Patient has had any major surgery with in past 4 weeks
* Patient is a current or past abuser of alcohol or illicit drugs

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
timeFrame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
timeFrame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
measure: Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
timeFrame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
measure: Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
timeFrame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
measure: Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
timeFrame: After first 2 weeks of treatment
measure: Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
timeFrame: After first 2 weeks of treatment
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
timeFrame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.