We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00521040
First Posted: August 27, 2007
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  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
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:


Further study details as provided by UCB Pharma:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 corticosteroid dependent asthma
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
  • contraindication for salbutamol use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521040


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00521040     History of Changes
Other Study ID Numbers: A00306
First Submitted: August 24, 2007
First Posted: August 27, 2007
Last Update Posted: December 12, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

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