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

Perennial Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894231
• Other study ID #: IIS071108
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2009
• Last updated: September 3, 2009
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: AAADRS Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• levocetirizine (Xyzal)
5mg po QD
• placebo
sugar tablet

Locations

Country	Name	City	State
United States	AAADRS	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AAADRS Clinical Research Center	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in objective measure of inflammation nasal NO after LC treatment.		two weeks	No
Secondary	The change in nasal eosinophils, QOL and diary scores after LC treatment.		two weeks	No