POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)

This study has been completed.

Sponsor:

Information provided by:

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00160537

First received: September 8, 2005

Last updated: December 13, 2013

Last verified: September 2009

History of Changes

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 4


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 Pharma:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	UCB Clinical Trial Call Center	UCB Pharma

More Information

Additional Information:

Clinical Study Summary on UCB.com This link exits the ClinicalTrials.gov site


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:	December 13, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016

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