Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eos... | NCT00894231

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

NCT00894231

Sponsor

AAADRS Clinical Research Center

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Perennial Allergic Rhinitis

Interventions

levocetirizine (Xyzal)
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Apr 17, 2009

First Submission Date that Met QC Criteria

May 4, 2009

First Posted Date

May 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	Sugar tablet	Drug: placebo
Xyzal	Active Comparator		Drug: levocetirizine (Xyzal)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levocetirizine (Xyzal)	Drug	5mg po QD	Xyzal	Xyzal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in objective measure of inflammation nasal NO after LC treatment.		two weeks

Secondary Outcomes

Measure	Description	Time Frame
The change in nasal eosinophils, QOL and diary scores after LC treatment.		two weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel J Lanz, MD	AAADRS Clinical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AAADRS		Coral Gables	Florida	33134	United States

Condition Browse Module

MeSH Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C472067	levocetirizine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided