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

This study has been completed.
UCB Pharma
Information provided by:
AAADRS Clinical Research Center
ClinicalTrials.gov Identifier:
First received: April 17, 2009
Last updated: September 3, 2009
Last verified: September 2009
The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.

Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: levocetirizine (Xyzal)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

Resource links provided by NLM:

Further study details as provided by AAADRS Clinical Research Center:

Primary Outcome Measures:
  • The change in objective measure of inflammation nasal NO after LC treatment. [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in nasal eosinophils, QOL and diary scores after LC treatment. [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Sugar tablet
Drug: placebo
sugar tablet
Active Comparator: Xyzal Drug: levocetirizine (Xyzal)
5mg po QD
Other Name: Xyzal


Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00894231

United States, Florida
Coral Gables, Florida, United States, 33134
Sponsors and Collaborators
AAADRS Clinical Research Center
UCB Pharma
Principal Investigator: Miguel J Lanz, MD AAADRS Clinical Research Center
  More Information

Responsible Party: Miguel J Lanz MD FAAAAI, AAADRS
ClinicalTrials.gov Identifier: NCT00894231     History of Changes
Other Study ID Numbers: IIS071108 
Study First Received: April 17, 2009
Last Updated: September 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Nitric Oxide
Anti-Allergic Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 03, 2016