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

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Bilastine (Drug); Fexofenadine (Drug); Cetirizine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Faes Farma, S.A.

Official(s) and/or principal investigator(s):
Friedrich Horak, Professor, Principal Investigator, Affiliation: ENT University Clinic Vienna

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.

Official title: A Randomized, Double-Blind, 4 Way Cross-Over, Placebo Controlled Trial to Evaluate the Onset of Action of Bilastine 20 mg vs. Placebo, Cetirizine 10 mg, and Fexofenadine 120 mg in the Vienna Challenge Chamber

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Onset of action and action duration

Secondary outcome:

Nasal and ocular symptom scores

Nasal airflow resistance

Nasal secretion weight

FEV1

Routine safety parameters (vital signs, ECGs, clinical laboratory tests)

Detailed 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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Allergy Center Vienna West, Vienna A-1150, Austria

Starting date: October 2006
Ending date: December 2006
Last updated: December 12, 2007