ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Information source: UCB
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Perennial
Intervention: Levocetirizine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Krassimir Mitchev, MD, PhD, Study Director, Affiliation: UCB
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.
Clinical Details
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 design: Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Evolution of the mean weekly T4SS (sum of the individual symptoms scores) during 6 months of treatment
Secondary outcome: 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 symptomsIntake of concomitant/rescue medication Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Genova, Italy
Additional Information
Starting date: March 2005
Ending date: June 2006
Last updated: July 10, 2007
|
