Phase 3
Completed N=1,577
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
Source: ClinicalTrials.gov NCT00979901 ↗Enrolled (actual)
1,577
Serious AEs
0.1%
Results posted
Jun 2010
Primary outcomePrimary: Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks — -0.24; -0.37; -0.47 Units on a Scale
Summary
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks |
-0.24; -0.37; -0.47 | — |
| SECONDARY Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks |
-0.14; -0.27; -0.23 | — |
| SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks |
-0.12; -0.26; -0.32 | — |
| SECONDARY Patient's Global Evaluation of Allergic Rhinitis at Week 2 |
2.62; 2.20; 2.13 | — |
| SECONDARY Physician's Global Evaluation of Allergic Rhinitis at Week 2 |
2.53; 2.23; 2.17 | — |
| SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 |
-0.65; -0.89; -0.99 | — |
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 and has been a nonsmoker for at least 1 year
- 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
Data sourced from ClinicalTrials.gov (NCT00979901). 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. Informational only — not medical advice.