Phase 3
N=1,214
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00972738 ↗Enrolled (actual)
1,214
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period — -0.38; -0.47; -0.29 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- montelukast sodium (Drug); Comparator: loratadine (Drug); Comparator: Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jul 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period |
-0.38; -0.47; -0.29 | — |
| SECONDARY Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period |
-0.28; -0.28; -0.20 | — |
| SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period |
-0.28; -0.40; -0.21 | — |
| SECONDARY Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period |
2.18; 2.19; 2.49 | — |
| SECONDARY Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period |
2.18; 2.16; 2.41 | — |
| SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period |
-0.90; -0.98; -0.66 | — |
Summary
This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
Eligibility Criteria
Inclusion Criteria
- Patient has a documented history of season 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 <8 weeks postpartum or is breast-feeding
- Patient has had major surgery in the past 4 weeks
- Patient intends to move or vacation away during the study
- Patient is a current or past abuser of alcohol or illicit drugs
Data sourced from ClinicalTrials.gov (NCT00972738). 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.