NCT00521040

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

December 12, 2013

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

August 24, 2007

Last Update Submit

December 11, 2013

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Levocetirizine dihydrochlorideXyzal tablets

Outcome Measures

Primary Outcomes (1)

  • T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)

    12 weeks

Secondary Outcomes (1)

  • 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

Interventions

Levocetirizine dihydrochlorideDRUG

Eligibility Criteria

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

You may qualify if:

  • male or female subjects ≥ 12 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

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

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

February 1, 2004

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

December 12, 2013

Record last verified: 2009-09