Phase 3 Completed N=890 Randomized Quadruple-blind Treatment

Safety Study of Olopatadine Nasal Spray

Perennial Allergic Rhinitis

Source: ClinicalTrials.gov NCT00578331 ↗

Enrolled (actual)

890

Serious AEs

3.4%

Results posted

Feb 2010

Primary outcomePrimary: Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire — 2.7; 2.5 Unit on PRRA scale

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.