Back to resultsSafety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Olopatadine nasal spray vehicle, pH 3.7
Olopatadine nasal spray vehicle, pH 7.0
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring nasal allergy, nasal spray, seasonal allergy, perennial allergy
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.
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
PATANASE
Patanase Vehicle, pH 3.7
Patanase Vehicle, pH 7.0
Arm Description
Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Outcomes
Primary Outcome Measures
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.
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."
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00789555
Brief Title
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Official Title
Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
nasal allergy, nasal spray, seasonal allergy, perennial allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PATANASE
Arm Type
Experimental
Arm Description
Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
Arm Title
Patanase Vehicle, pH 3.7
Arm Type
Placebo Comparator
Arm Description
Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Arm Title
Patanase Vehicle, pH 7.0
Arm Type
Placebo Comparator
Arm Description
Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Other Intervention Name(s)
PATANASE®
Intervention Description
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Intervention Type
Other
Intervention Name(s)
Olopatadine nasal spray vehicle, pH 3.7
Intervention Description
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Intervention Type
Other
Intervention Name(s)
Olopatadine nasal spray vehicle, pH 7.0
Intervention Description
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Primary Outcome Measure Information:
Title
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
Description
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.
Time Frame
Baseline (Day 0), Exit (Month 12 or sooner)
Title
Self-Rated Relief Assessment at Day 30
Description
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."
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
Description
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.
Time Frame
Baseline (Day 0), Exit (Month 12 or sooner)
Title
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
Description
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.
Time Frame
Baseline (Day 0), Exit (Month 12 or sooner)
Title
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
Description
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.
Time Frame
Baseline (Day 0), Exit (Month 12 or sooner)
Title
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
Description
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.
Time Frame
Baseline (Day 0), Exit (Month 12 or sooner)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
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