POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis) - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160537

Purpose

Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Levocetirizine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Subjects' satisfaction / dissatisfaction after the first week of treatment.

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	May 2005
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160537

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00160537 History of Changes
Other Study ID Numbers:	A00391, EudraCT 2004-002971-18, POPULAR
Study First Received:	September 8, 2005
Last Updated:	September 9, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:

Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion)
POPULAR, Xyzal, Levocetirizine

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Levocetirizine

Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012