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ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 8, 2005
Last updated: December 13, 2013
Last verified: September 2009
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: 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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00160680

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

Additional Information: Identifier: NCT00160680     History of Changes
Other Study ID Numbers: A00392
EudraCT 2004-003858-26
Study First Received: September 8, 2005
Last Updated: December 13, 2013

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, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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 processed this record on August 16, 2017