Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levocetirizine dihydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Levocetirizine dihydrochloride, Xyzal tablets
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
Sites / Locations
Outcomes
Primary Outcome Measures
T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521040
Brief Title
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Official Title
Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levocetirizine dihydrochloride
Primary Outcome Measure Information:
Title
T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
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