Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perennial Allergic Rhinitis
Intervention: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) (Drug); Olopatadine nasal spray vehicle, pH 3.7 (Other); Olopatadine nasal spray vehicle, pH 7.0 (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
Summary
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).
Clinical Details
Official title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)Self-Rated Relief Assessment at Day 30
Secondary outcome: Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
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 allergy testing;
5. Age 12 years and older;
6. Must follow instructions;
7. Must make required study visits;
8. Negative pregnancy test and adequate birth control methods for females of
childbearing potential;
9. Refrain from certain allergy medications during the study;
10. Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
1. Nasal disorders;
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, 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;
9. Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: November 2008
Last updated: August 8, 2012
|
