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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 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 (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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT00894231     History of Changes
Other Study ID Numbers: IIS071108
Study First Received: April 17, 2009
Last Updated: September 3, 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
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors processed this record on June 23, 2017