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

Phase 4

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: placebo; Drug: levocetirizine (Xyzal)

• Registration Number: NCT00894231
• Lead Sponsor: AAADRS Clinical Research Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-03
• Last Update Posted: 2009-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Sugar tablet
Xyzal	levocetirizine (Xyzal)	-

Primary Outcome Measures

Name	Time	Method
The change in objective measure of inflammation nasal NO after LC treatment.	two weeks

Secondary Outcome Measures

Name	Time	Method
The change in nasal eosinophils, QOL and diary scores after LC treatment.	two weeks

Trial Locations

Locations (1)

AAADRS; 🇺🇸 Coral Gables, Florida, United States