Phase 4 N=1,260 Randomized Triple-blind Treatment

Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00789555 ↗

Enrolled (actual)

1,260

Serious AEs

2.3%

Results posted

Sep 2012

Primary outcome: Primary: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) — 0.8; 1.3; 0.3; 0.8 Percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) (Drug); Olopatadine nasal spray vehicle, pH 3.7 (Other); Olopatadine nasal spray vehicle, pH 7.0 (Other)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)	0.8; 1.3; 0.3; 0.8; 1.0; 2.6	—
PRIMARY Self-Rated Relief Assessment at Day 30	2.4; 2.7; 2.7	—
SECONDARY Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)	0.0; 0.0; 0.0; 0.7; 1.2; 0.5	—
SECONDARY Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)	0.5; 1.2; 0.5; 1.0; 2.4; 2.4	—
SECONDARY Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)	0.0; 0.2; 0.2; 0.7; 1.0; 0.5	—
SECONDARY Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)	5.2; 4.2; 4.6; 0.0; 0.7; 0.0	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00789555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.