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ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00160680
First Posted: September 12, 2005
Last Update Posted: October 12, 2017
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
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.

Condition Intervention Phase
Rhinitis, Allergic, Perennial Drug: Levocetirizine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Pilot, Open, Monocenter Randomized Two Parallel Groups, Clinical Efficacy Trial: Comparison Continuous Versus on Demand Regimen of Treatment With Levocetirizine 5 mg Oral Tablets, Once a Day, in Adults Suffering From Persistent Allergic Rhinitis (PER) Over 6 Months

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Evolution of the mean weekly T4SS (sum of the individual symptoms scores) during 6 months of treatment

Secondary Outcome Measures:
  • Evolution of inflammatory cells concentrations and expression of ICAM-1 in nasal scrapings at baseline/after 1, 3 and 6 months of treatment Evolution of Rhinasthma scores, weekly/monthly number of days with (acute) rhinitis symptoms
  • Intake of concomitant/rescue medication
  • Safety

Estimated Enrollment: 100
Study Start Date: March 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Clinical history of PER requiring treatment known at least since 2 years.
  • Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to HDM and Parietaria (less than 1 year).
  • Minimum mean T4SS of 6 over baseline period.

Exclusion Criteria:

  • Subjects currently treated by specific parietaria pollen immunotherapy
  • Subjects suffering from non-allergic asthma
  • Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
  • Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
  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): NCT00160680


Locations
Italy
Genova, Italy
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00160680     History of Changes
Other Study ID Numbers: A00392
EudraCT 2004-003858-26
ATAREAL
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: October 12, 2017
Last Verified: September 2009

Keywords provided by UCB Pharma:
Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
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