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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:
ClinicalTrials.gov Identifier:
NCT00894231
First Posted: May 6, 2009
Last Update Posted: September 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by:
AAADRS Clinical Research Center
  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: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • The change in nasal eosinophils, QOL and diary scores after LC treatment. [ Time Frame: two weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894231


Locations
United States, Florida
AAADRS
Coral Gables, Florida, United States, 33134
Sponsors and Collaborators
AAADRS Clinical Research Center
UCB Pharma
Investigators
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
First Submitted: April 17, 2009
First Posted: May 6, 2009
Last Update Posted: September 4, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
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
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists