- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789555
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
January 12, 2018 updated by: Alcon Research
Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1260
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PATANASE
Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
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Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Other Names:
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Placebo Comparator: Patanase Vehicle, pH 3.7
Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
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Two sprays in each nostril twice a day (morning and evening) for up to 12 months
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Placebo Comparator: Patanase Vehicle, pH 7.0
Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
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Two sprays in each nostril twice a day (morning and evening) for up to 12 months
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What is the study measuring?
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)
Time Frame: Baseline (Day 0), Exit (Month 12 or sooner)
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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.
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Baseline (Day 0), Exit (Month 12 or sooner)
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Self-Rated Relief Assessment at Day 30
Time Frame: Day 30
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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."
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Day 30
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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)
Time Frame: Baseline (Day 0), 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.
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Baseline (Day 0), Exit (Month 12 or sooner)
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Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
Time Frame: Baseline (Day 0), Exit (Month 12 or sooner)
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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.
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Baseline (Day 0), Exit (Month 12 or sooner)
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Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
Time Frame: Baseline (Day 0), Exit (Month 12 or sooner)
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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.
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Baseline (Day 0), Exit (Month 12 or sooner)
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Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
Time Frame: Baseline (Day 0), 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.
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Baseline (Day 0), Exit (Month 12 or sooner)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
November 11, 2008
First Submitted That Met QC Criteria
November 11, 2008
First Posted (Estimate)
November 13, 2008
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
January 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Olopatadine Hydrochloride
Other Study ID Numbers
- C-08-32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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