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

Verified by: UCB, Inc., September 2009
First Received: August 24, 2007 | Last Updated: September 9, 2009 | Phase: N/A | Start Date: February 2004
Overall Status: Completed | Estimated Enrollment: 459
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Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With...

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

  • Drug: Levocetirizine dihydrochloride

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary 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
    • Time Frame: 12 weeks

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director UCB, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521040

Study ID Number: A00306

ClinicalTrials.gov Identifier: NCT00521040

Health Authority: Belgium: Federal Agency for Medicines and Health Products

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