ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life) - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160680

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 IV

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
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

Further study details as provided by UCB:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160680

Locations

Italy

Genova, Italy

Sponsors and Collaborators

UCB

Investigators

Study Director:

Krassimir Mitchev, MD, PhD

UCB

More Information

Study ID Numbers:	A00392, EudraCT 2004-003858-26, ATAREAL
Study First Received:	September 8, 2005
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00160680
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by UCB:

Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine

Study placed in the following topic categories:

Pruritus
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial

Levocetirizine
Hypersensitivity, Immediate
Histamine phosphate
Rhinitis
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009