search
Back to results

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

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levocetirizine (Xyzal)
placebo
Sponsored by
AAADRS Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AAADRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Xyzal

Arm Description

Sugar tablet

Outcomes

Primary Outcome Measures

The change in objective measure of inflammation nasal NO after LC treatment.

Secondary Outcome Measures

The change in nasal eosinophils, QOL and diary scores after LC treatment.

Full Information

First Posted
April 17, 2009
Last Updated
September 3, 2009
Sponsor
AAADRS Clinical Research Center
Collaborators
UCB Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT00894231
Brief Title
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Official Title
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AAADRS Clinical Research Center
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Sugar tablet
Arm Title
Xyzal
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
levocetirizine (Xyzal)
Other Intervention Name(s)
Xyzal
Intervention Description
5mg po QD
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sugar tablet
Primary Outcome Measure Information:
Title
The change in objective measure of inflammation nasal NO after LC treatment.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
The change in nasal eosinophils, QOL and diary scores after LC treatment.
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel J Lanz, MD
Organizational Affiliation
AAADRS Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AAADRS
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs