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Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00544388
First received: October 15, 2007
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
 Drug: levocetirizine dihydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary Outcome Measures:
  • Mean change from baseline in MSC score over each 2-hour interval.

Enrollment: 570
Study Start Date: April 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/Female, aged >= 16 years
  • seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
  • documented seasonal allergy to ragweed pollen
  • total symptom score of at least 18 points.

Exclusion Criteria:

  • nasal anatomic deformities ? 50% obstruction
  • acute sinusitus within 30 days of Period 2
  • initiatedor advanced an immunotherapy regimen
  • immunotherapy injections within 48 hours of pollen exposure
  • impaired hepatic function
  • history of malignancy
  • intolerance to histamines
  • astma requiring medication more than occasional
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544388

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

No publications provided

ClinicalTrials.gov Identifier: NCT00544388     History of Changes
Other Study ID Numbers: A00379
Study First Received: October 15, 2007
Last Updated: September 9, 2009
Health Authority: Canada: Health Canada

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

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
Cetirizine
 Levocetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012