Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

NCT ID: NCT00894231

Last Updated: 2009-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Sugar tablet

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

sugar tablet

Xyzal

Group Type ACTIVE_COMPARATOR

levocetirizine (Xyzal)

Intervention Type DRUG

5mg po QD

Interventions

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levocetirizine (Xyzal)

5mg po QD

Intervention Type DRUG

placebo

sugar tablet

Intervention Type DRUG

Other Intervention Names

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Xyzal

Eligibility Criteria

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Inclusion Criteria

* ICF signed
* Diagnosis of PAR for 6-12 months greater
* 12 years and older
* Decreased nasal NO values at baseline
* Compliance and ability to perform maneuvers and responsibilities

Exclusion Criteria

* Oral or systemic steroids for 60 days prior
* Inhaled, nasal, nebulized steroids w/i 4 weeks
* Hospitalization or life threatening asthma
* Use of nasal or oral antihistamines w/i 4 weeks
* Upper or lower airways infection
* Direct cigarette smoke exposure
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

AAADRS Clinical Research Center

OTHER

Sponsor Role lead

Responsible Party

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AAADRS

Principal Investigators

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Miguel J Lanz, MD

Role: PRINCIPAL_INVESTIGATOR

AAADRS Clinical Research Center

Locations

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AAADRS

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IIS071108

Identifier Type: -

Identifier Source: org_study_id

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