NCT00894231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

April 17, 2009

Last Update Submit

September 3, 2009

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

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

    two weeks

Secondary Outcomes (1)

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

    two weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Sugar tablet

Drug: placebo

Xyzal

ACTIVE COMPARATOR
Drug: levocetirizine (Xyzal)

Interventions

levocetirizine (Xyzal)DRUG

5mg po QD

Also known as: Xyzal
Xyzal
placeboDRUG

sugar tablet

placebo

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ICF signed
  • Diagnosis of PAR for 6-12 months greater
  • years and older
  • Decreased nasal NO values at baseline
  • Compliance and ability to perform maneuvers and responsibilities

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AAADRS

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Miguel J Lanz, MD

    AAADRS Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2009

First Posted

May 6, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

US(1)