Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00542607
First received: October 10, 2007
Last updated: December 11, 2013
Last verified: September 2009
  Purpose

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: levocetirizine dihydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcome Measures:
  • The change from baseline of the mean MSC score over time interval 3
  • the change from baseline of the mean MSC score over time intervals 1 and 4.

Enrollment: 94
Study Start Date: September 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults 18 to 55 years both inclusive
  • suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
  • positive RAST and/or positive skin prick test
  • comply with study restrictions

Exclusion Criteria:

  • known alcohol or drug addiction or abuse
  • known allergy/intolerance to lactose, cellulose, cornstarch
  • presence of nasal anatomical deformities leading to > 50% obstruction
  • ENT infection within 30 days of the study
  • use of disallowed medication
  • ongoing desensitization
  • known cardiac, renal or hepatic dysfunction
  • presenting allergic bronchial asthma
  • use of cimetidine
  • intending to donate blood during the trial
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542607

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00542607     History of Changes
Other Study ID Numbers: A00324
Study First Received: October 10, 2007
Last Updated: December 11, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

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
Fexofenadine
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 August 28, 2014