Safety Study of Olopatadine Nasal Spray

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Olopatadine 0.6% nasal spray; Drug: Placebo Nasal Spray

• Registration Number: NCT00578331
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-07-07
• Results First Submitted QC: 2010-01-08
• Status Verified: 2010-02
• Results First Posted: 2010-02-03
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

Inclusion Criteria

• Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria

• Age 11 years and younger

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olopatadine 0.6% Nasal Spray	Olopatadine 0.6% nasal spray	2 sprays each nostril twice daily
Placebo Nasal Spray	Placebo Nasal Spray	2 sprays each nostril twice daily

Primary Outcome Measures

Name	Time	Method
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire	day 30	Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.

Secondary Outcome Measures

Name	Time	Method
Average Number of Days of Rescue Medication Taken	Month 1 through Month 12

Trial Locations

Locations (1)

Waco; 🇺🇸 Waco, Texas, United States