Phase 3
N=1,365
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00974571 ↗Enrolled (actual)
1,365
Serious AEs
0.4%
Results posted
Jun 2010
Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score — -0.39; -0.45; -0.36 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- montelukast sodium (Drug); Comparator: cetirizine (Drug); Comparator: placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- May 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score |
-0.39; -0.45; -0.36 | — |
| SECONDARY Mean Change From Baseline in Nighttime Symptoms Score |
-0.28; -0.30; -0.26 | — |
| SECONDARY Mean Change From Baseline in Composite Symptoms Score |
-0.34; -0.38; -0.30 | — |
| SECONDARY Patient's Global Evaluation of Allergic Rhinitis |
2.22; 2.15; 2.41 | — |
| SECONDARY Physician's Global Evaluation of Allergic Rhinitis |
2.26; 2.20; 2.33 | — |
Summary
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
Eligibility Criteria
Inclusion Criteria
- Patient has a documented clinical history of perennial allergic rhinitis
- Patient is a nonsmoker
- Patient is in good general health
Exclusion Criteria
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast-feeding
- Patient is a current or past abuser of alcohol or illicit drugs
Data sourced from ClinicalTrials.gov (NCT00974571). 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.