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

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

    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

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:

  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.

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
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Other Names:
  • PATANASE®
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
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
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
Two sprays in each nostril twice a day (morning and evening) for up to 12 months

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)
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
Time Frame: 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)
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.
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)
Time Frame: Baseline (Day 0), 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)
Time Frame: Baseline (Day 0), 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)
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.
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

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.

Clinical Trials on Perennial Allergic Rhinitis

Clinical Trials on Olopatadine hydrochloride 0.6% nasal spray (PATANASE)

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