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”

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.

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: Bilastine
  • Encapsulated Bilastine 20 mg tablets Q.D.
• Drug: Fexofenadine
  • Encapsulated Fexofenadine 120 mg tablets Q.D.
• Drug: Cetirizine
  • Encapsulated Cetirizine 10 mg tablets Q.D.
• Drug: Placebo
  • Encapsulated Placebo tablets Q.D.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Bilastine 20 mg
• Active Comparator: 2
  • Fexofenadine 120 mg
• Active Comparator: 3
  • Cetirizine 10 mg
• Placebo Comparator: 4
  • Placebo

Primary Measures

• Onset of action and action duration
  • Safety Issue?: No

Secondary Measures

• Nasal and ocular symptom scores
  • Safety Issue?: No
• Nasal airflow resistance
  • Safety Issue?: No
• Nasal secretion weight
  • Safety Issue?: No
• FEV1
  • Safety Issue?: No
• Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
  • Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Faes Farma, S.A.

Overall Clinical Trial Officials and Contacts

Friedrich Horak, Professor Principal Investigator ENT University Clinic Vienna  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00420082

Study ID Number: BILA-2306/ACC

ClinicalTrials.gov Identifier: NCT00420082

Health Authority: Austria: Agency for Health and Food Safety