Efficacy and Safety of Levocetirizine 8 Weeks Prior and A... | NCT00521040

Studies
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

NCT00521040

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

459Actual

Phase

Not Applicable

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Levocetirizine dihydrochloride

Countries

Not provided

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

Feb 2004

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

Aug 24, 2007

First Submission Date that Met QC Criteria

Aug 24, 2007

First Posted Date

Aug 27, 2007Estimated

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

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

459Actual

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine dihydrochloride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female subjects ≥ 12 years
2 year history of seasonal allergic rhinitis
documented hypersensitivity to local seasonal allergens (grass pollen)
documented pollen-induced asthma
without acute ongoing exacerbation of asthma or allergic rhinitis
no continuous ongoing treatment for rhinitis or asthma

Exclusion Criteria:

non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
symptomatic rhinitis or asthma due to tree pollens
currently treated by specific grass pollen immunotherapy
suffering from non-allergic asthma
chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
contraindication for salbutamol use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
UCB Clinical Trial Call Center	UCB Pharma	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal

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