ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

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. Identifier: NCT00160680
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2013
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Levocetirizine Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. 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
  2. Intake of concomitant/rescue medication
  3. Safety

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT00160680

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

Additional Information: Identifier: NCT00160680     History of Changes
Other Study ID Numbers: A00392
EudraCT 2004-003858-26
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 16, 2013
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, 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