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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00521040
First received: August 24, 2007
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention
Rhinitis, Allergic, Seasonal
 Drug: Levocetirizine dihydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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

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 [ Time Frame: 12 weeks ]

Enrollment: 459
Study Start Date: February 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521040

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00521040     History of Changes
Other Study ID Numbers: A00306
Study First Received: August 24, 2007
Last Updated: September 9, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products

Keywords provided by UCB, Inc.:
Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Levocetirizine
 Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013