Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perennial Allergic Rhinitis
Intervention: PATANASE nasal spray (Drug); Olopatadine Nasal Spray vehicle (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
Summary
This study is being conducted to obtain additional safety data for PATANASE Nasal Spray
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: Changes in nasal exam from baseline at 12 months
Secondary outcome: Changes in physical exam parameters at 12 months
Changes in cardiovascular parameters at 12 months
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Sign informed consent
2. Normal nasal exam
3. History of perennial allergic rhinitis
4. Allergy to perennial allergen documented by skin in vitro test
5. Age 12 and older
6. Patient must follow instructions
7. Patient must make required study visits
8. Negative pregnancy test
9. Refrain from certain allergy medications during the study
Exclusion Criteria:
1. Nasal disorders
2. Use of substances that affect the nasal septum
3. Exposure to industrial metal plating solutions
4. Uncontrolled, sever, or unstable diseases
5. Hypersensitivity to the study drug or nasal spray components
6. Relative of site staff with access to the protocol
7. Participation in another investigational study within 30 days or at the same time as
this study
8. Medical Monitor decision
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Alcon Call Center
Additional Information
Starting date: November 2008
Last updated: January 23, 2009
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