Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

NCT00789555 | Completed Phase 4 Results

• 1 other identifier: C-08-32
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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).

Conditions

Perennial Allergic Rhinitis

Keywords

nasal allergy; nasal spray; seasonal allergy; perennial allergy

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to 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

  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 Outcomes (4)

• Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)

  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)

  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)

  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)

  Baseline (Day 0), Exit (Month 12 or sooner)

Study Arms (3)

PATANASE

EXPERIMENTAL

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)

Patanase Vehicle, pH 3.7

PLACEBO COMPARATOR

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

Patanase Vehicle, pH 7.0

PLACEBO COMPARATOR

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

Interventions

Olopatadine hydrochloride 0.6% nasal spray (PATANASE) DRUG

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

Also known as: PATANASE®

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

Patanase Vehicle, pH 3.7

Olopatadine nasal spray vehicle, pH 7.0 OTHER

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

Patanase Vehicle, pH 7.0

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Interventions

Olopatadine Hydrochloride; Nasal Sprays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Terri Pasquine, Sr. Clinical Lead
• Organization: Alcon Research

terri.pasquine@alconlabs.com

817-551-4760

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 8, 2018
• Results First Posted: September 7, 2012

Record last verified: 2018-01

Locations

US (1)