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

AAADRS Clinical Research Center

Status and phase: Completed; Phase 4

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: placebo; Drug: levocetirizine (Xyzal)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00894231

IIS071108

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Sugar tablet

Treatment:

Drug: placebo

Xyzal

Active Comparator group

Treatment:

Drug: levocetirizine (Xyzal)