Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

NCT ID: NCT00979615

Last Updated: 2011-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Detailed Description

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Conditions

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Vasomotor Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Olopatadine HCL Nasal Spray, 0.6%

Group Type EXPERIMENTAL

Olopatadine HCL (Patanase) Nasal Spray, 0.6%

Intervention Type DRUG

2 sprays/ nostril BID

2

Azelastine HCl Nasal Spray, 137 mcg

Group Type ACTIVE_COMPARATOR

Azelastine HCl (Astelin) Nasal Spray, 137 mcg

Intervention Type DRUG

2 sprays/ nostril BID

Interventions

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Olopatadine HCL (Patanase) Nasal Spray, 0.6%

2 sprays/ nostril BID

Intervention Type DRUG

Azelastine HCl (Astelin) Nasal Spray, 137 mcg

2 sprays/ nostril BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
* Negative skin tests to a panel of allergens and positive histamine test within last 2 years
* History of symptoms related to defined VMR triggers

Exclusion Criteria

* Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
* Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
* Chronic use of drugs that can cause rhinitis
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Research Ltd

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-09-03

Identifier Type: -

Identifier Source: org_study_id

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