Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521040
• Other study ID #: A00306
• Status: Completed
• Phase: N/A
• First received: August 24, 2007
• Last updated: December 11, 2013
• Start date: February 2004
• Est. completion date: July 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• male or female subjects = 12 years

• 2 year history of seasonal allergic rhinitis

• documented hypersensitivity to local seasonal allergens (grass pollen)

• documented pollen-induced asthma

• without acute ongoing exacerbation of asthma or allergic rhinitis

• no continuous ongoing treatment for rhinitis or asthma

Exclusion Criteria:

• non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity

• symptomatic rhinitis or asthma due to tree pollens

• currently treated by specific grass pollen immunotherapy

• suffering from non-allergic asthma

• chronic use of inhaled steroids and/or long acting ß2 agonists; and/or corticosteroid dependent asthma

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

• contraindication for salbutamol use

Study Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

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	T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)		12 weeks
Secondary	Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season		12 weeks

External Links

•   Clinical Study Summary on UCB.com