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OpenTrials
Completed

NCT Number: NCT00578331

Safety Study of Olopatadine Nasal Spray

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.

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Waco

Waco, Texas, 76712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age 11 years and younger

Treatment and study plan

Olopatadine 0.6% nasal spray

Drug

2 sprays each nostril twice daily

Placebo nasal spray

Drug

2 sprays each nostril twice daily

Primary outcomes

  1. Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire

    Time frame: 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 outcomes

  1. Average Number of Days of Rescue Medication Taken

    Time frame: Month 1 through Month 12

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 21, 2007
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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