POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160537
• Other study ID #: A00391
• Secondary ID: EudraCT 2004-002
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: December 13, 2013
• Start date: May 2005
• Est. completion date: July 2005

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Levocetirizine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary	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

External Links

•   Clinical Study Summary on UCB.com