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Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00789555
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : September 7, 2012
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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).

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
Study Start Date : November 2008
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789555


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00789555     History of Changes
Other Study ID Numbers: C-08-32
First Posted: November 13, 2008    Key Record Dates
Results First Posted: September 7, 2012
Last Update Posted: February 8, 2018
Last Verified: January 2018

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

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