ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00544388
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: levocetirizine dihydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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).
Study Start Date : April 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

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




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

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


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:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 sinusitis within 30 days of Period 2
  • initiated or advanced an immunotherapy regimen
  • immunotherapy injections within 48 hours of pollen exposure
  • impaired hepatic function
  • history of malignancy
  • intolerance to histamines
  • asthma requiring medication more than occasionally

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): NCT00544388


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00544388     History of Changes
Other Study ID Numbers: A00379
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablet

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