Clinical trial NCT00963599: Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study
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: 907
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score
timeFrame: Baseline and Week 2
measure: Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Eye Symptoms Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Nasal Congestion Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Rhinorrhea Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Nasal Itching Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Sneezing Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Nasal Congestion Upon Awakening
timeFrame: Baseline and Week 2
measure: Patient's Global Evaluation of Allergic Rhinitis
timeFrame: Week 2
measure: Physician's Global Evaluation of Allergic Rhinitis
timeFrame: Week 2
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
timeFrame: Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.