Phase 3
Completed N=1,992
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
Rhinitis, Allergic, Perennial
Source: ClinicalTrials.gov NCT00092118 ↗
Enrolled (actual)
1,992
Serious AEs
0.3%
Results posted
Jul 2010
Primary outcomePrimary: Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis — -0.37; -0.44 Score on a scale
Summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis |
-0.37; -0.44 | — |
| SECONDARY Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period |
2.42; 2.27 | — |
| SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period |
-0.69; -0.84 | — |
Eligibility Criteria
Inclusion Criteria
- Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing
Exclusion Criteria
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Data sourced from ClinicalTrials.gov (NCT00092118). 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.