A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

Faes Farma

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Cetirizine; Drug: Fexofenadine; Drug: Bilastine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420082

2006-003004-19 (EudraCT Number)

BILA-2306/ACC

Details and patient eligibility

About

This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.

Full description

The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.

Enrollment: 75 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a history of seasonal allergic rhinitis
• Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit

Exclusion criteria

• Have a clinically significant illness or disease
• Have unstable asthma
• Has participated in a clinical trial 30 days prior to the screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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75 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Bilastine 20 mg

Treatment:

Drug: Bilastine

2

Active Comparator group

Description:

Fexofenadine 120 mg

Treatment:

Drug: Fexofenadine

3

Active Comparator group

Description:

Cetirizine 10 mg

Treatment:

Drug: Cetirizine

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo