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Completed

NCT Number: NCT00789555

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).

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine hydrochloride 0.6% nasal spray (PATANASE)

Drug

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Other names: PATANASE®

Olopatadine nasal spray vehicle, pH 3.7

Other

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Olopatadine nasal spray vehicle, pH 7.0

Other

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Primary outcomes

  1. 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.

  2. 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."

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 13, 2008
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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