Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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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).

Official Title
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Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
* Other: Olopatadine nasal spray vehicle, pH 3.7
* Other: Olopatadine nasal spray vehicle, pH 7.0


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATANASE<br>Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months | Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)<br>* Two sprays in each nostril twice a day (morning and evening) for up to 12 months<br>* Other names: PATANASE®;|
| Placebo Comparator: Patanase Vehicle, pH 3.7<br>Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months | Other: Olopatadine nasal spray vehicle, pH 3.7<br>* Two sprays in each nostril twice a day (morning and evening) for up to 12 months<br>|
| Placebo Comparator: Patanase Vehicle, pH 7.0<br>Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months | Other: Olopatadine nasal spray vehicle, pH 7.0<br>* Two sprays in each nostril twice a day (morning and evening) for up to 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | Baseline (Day 0), Exit (Month 12 or sooner) | 
| Self-Rated Relief Assessment at Day 30 | Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes. | Baseline (Day 0), 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 in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure. | Baseline (Day 0), 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 change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure. | Baseline (Day 0), 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) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | Baseline (Day 0), Exit (Month 12 or sooner) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal allergy, nasal spray, seasonal allergy, perennial allergy