Phase 3
N=890
Safety Study of Olopatadine Nasal Spray
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00578331 ↗Enrolled (actual)
890
Serious AEs
3.4%
Results posted
Feb 2010
Primary outcome: Primary: Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire — 2.7; 2.5 Unit on PRRA scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olopatadine 0.6% nasal spray (Drug); Placebo Nasal Spray (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire |
2.7; 2.5 | — |
| SECONDARY Average Number of Days of Rescue Medication Taken |
10.2; 11.8 | — |
Summary
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Exclusion Criteria
- Age 11 years and younger
Data sourced from ClinicalTrials.gov (NCT00578331). 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.