Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00789555
First received: November 11, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Other: Olopatadine nasal spray vehicle, pH 3.7
Other: Olopatadine nasal spray vehicle, pH 7.0
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Day 0), Exit (Month 12 or sooner) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (Day 0), Exit (Month 12 or sooner) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (Day 0), Exit (Month 12 or sooner) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (Day 0), Exit (Month 12 or sooner) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1260
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Other Name: 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
Other: Olopatadine nasal spray vehicle, pH 3.7
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
Other: Olopatadine nasal spray vehicle, pH 7.0
Two sprays in each nostril twice a day (morning and evening) for up to 12 months

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789555

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00789555     History of Changes
Other Study ID Numbers: C-08-32
Study First Received: November 11, 2008
Results First Received: August 8, 2012
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Alcon Research:
nasal allergy
nasal spray
seasonal allergy
perennial allergy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Olopatadine
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014