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

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. Identifier: NCT00894231
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : September 4, 2009
UCB Pharma
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: levocetirizine (Xyzal) Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
Sugar tablet
Drug: placebo
sugar tablet
Active Comparator: Xyzal Drug: levocetirizine (Xyzal)
5mg po QD
Other Name: Xyzal

Primary Outcome Measures :
  1. The change in objective measure of inflammation nasal NO after LC treatment. [ Time Frame: two weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): 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

Responsible Party: Miguel J Lanz MD FAAAAI, AAADRS Identifier: NCT00894231     History of Changes
Other Study ID Numbers: IIS071108
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

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