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NCT00521131 Clinical Trial

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Rhinitis Clinical Trial

Official title:
Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00521131
Other study ID # A00333
Secondary ID
Status Completed
Phase Phase 4
First received August 24, 2007
Last updated December 13, 2013
Start date September 2002
Est. completion date May 2003

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life Sciences
Study type Interventional

Clinical Trial Summary

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Recruitment information / eligibility
Status Completed
Enrollment 453
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- male or female = 12 years

- suffering from a perennial allergic rhinitis to house dust mites for at least 2 years

- positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites

- the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was = 5

Exclusion Criteria:

- seasonal allergic rhinitis likely to change significantly the symptoms of the subject

- an ear, nose or throat (ENT) infection during the two weeks preceding initial visit

- asthma requiring corticosteroid treatment

- atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids

- associated ENT disease

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Levocetirizine dihydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Number of comfortable days, as assessed by the subject 30 days
Secondary Sum of 4 and 5 rhinitis symptoms and safety Week 1 and over 30 days
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