POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
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
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as
measured by the subject's satisfaction/dissatisfaction after one week of treatment
Clinical Details
Official title: A Monocenter, Double-Blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary outcome: allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical history of SAR known and treated since 2 years.
- Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3. 5
IU/ml) to grass pollen (less than 1 year).
- Minimum mean T5SS of 8 during the baseline period.
Exclusion Criteria:
- Have an associated asthma requiring a daily treatment other than β2 short acting
agonist prn
- Have atopic dermatitis or urticaria requiring antihistamine treatment or the
administration of oral or topical corticosteroids and any other disease requiring the
administration of oral or topical corticosteroids
Locations and Contacts
Additional Information
Starting date: May 2005
Ending date: July 2005
Last updated: March 6, 2008
|