Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

Completed · Phase 4

Conditions studied: Perennial Allergic Rhinitis

In brief

The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).

Key facts

Study ID

NCT00789555

Run by

Alcon Research

People needed

1260

Starts

2008-11-01

Expected to finish

2011-01-01

Last updated by the study team

2018-02-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign informed consent;
• Normal nasal exam;
• History of perennial allergic rhinitis;
• Allergy to perennial allergen documented by allergy testing;
• Age 12 years and older;
• Must follow instructions;
• Must make required study visits;
• Negative pregnancy test and adequate birth control methods for females of childbearing potential;
• Refrain from certain allergy medications during the study;
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Nasal disorders;
• Use of substances that affect the nasal septum;
• Exposure to industrial metal plating solutions;
• Uncontrolled, severe, or unstable diseases;
• Hypersensitivity to the study drug or nasal spray components;
• Relative of site staff with access to the protocol;
• Participation in another investigational study within 30 days or at the same time as this study;
• Medical Monitor decision;
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Contact Alcon Call Center For Trial Locations — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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