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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420082
• Other study ID #: BILA-2306/ACC
• Secondary ID: 2006-003004-19
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2007
• Last updated: April 4, 2012
• Start date: October 2006
• Est. completion date: December 2006

Study information

• Verified date: April 2012
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

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

Locations

Country	Name	City	State
Austria	Allergy Center Vienna West	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Faes Farma, S.A.

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of action and action duration			No
Secondary	Nasal and ocular symptom scores			No
Secondary	Nasal airflow resistance			No
Secondary	Nasal secretion weight			No
Secondary	FEV1			No
Secondary	Routine safety parameters (vital signs, ECGs, clinical laboratory tests)			Yes