Phase 3 N=907 Randomized Double-blind Treatment

Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00963599 ↗

Enrolled (actual)

907

Serious AEs

0.1%

Results posted

Jun 2010

Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score — -0.26; -0.48; -0.52; -0.58 Units on a Scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: montelukast/loratadine (Drug); Comparator: montelukast (Drug); Comparator: loratadine (Drug); Comparator: placebo (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Nov 1999

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score	-0.26; -0.48; -0.52; -0.58	—
SECONDARY Mean Change From Baseline in Nighttime Symptoms Score	-0.12; -0.29; -0.26; -0.28	—
SECONDARY Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	-0.2; -0.40; -0.41; -0.45	—
SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score	-0.14; -0.35; -0.38; -0.41	—
SECONDARY Mean Change From Baseline in Daytime Nasal Congestion Score	-0.19; -0.41; -0.39; -0.43	—
SECONDARY Mean Change From Baseline in Daytime Rhinorrhea Score	-0.25; -0.53; -0.51; -0.59	—
SECONDARY Mean Change From Baseline in Daytime Nasal Itching Score	-0.26; -0.49; -0.56; -0.62	—
SECONDARY Mean Change From Baseline in Daytime Sneezing Score	-0.26; -0.46; -0.59; -0.67	—
SECONDARY Mean Change From Baseline in Nasal Congestion Upon Awakening	-0.15; -0.35; -0.30; -0.32	—
SECONDARY Patient's Global Evaluation of Allergic Rhinitis	2.37; 2.10; 2.00; 1.92	—
SECONDARY Physician's Global Evaluation of Allergic Rhinitis	2.35; 2.13; 2.05; 1.99	—
SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score	-0.80; -1.09; -1.06; -1.16	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00963599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.