Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: Levocetirizine dihydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen
Season in Subjects With SAR
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
Secondary outcome: 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
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
corticosteroiddependent asthma
- atopic dermatitis or urticaria requiring an antihistamine treatment or the
administration of oral or topical corticosteroids
- contraindication for salbutamol use
Locations and Contacts
Additional Information
Starting date: February 2004
Ending date: July 2004
Last updated: March 6, 2008
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