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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
AAADRS Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00894231
First received: April 17, 2009
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Levocetirizine
Cetirizine
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on June 18, 2013