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

Sponsor

Faes Farma, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00420082

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

37.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Bilastine Drug: Fexofenadine Drug: Cetirizine Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Bilastine 20 mg	Drug: Bilastine Encapsulated Bilastine 20 mg tablets Q.D.
Active Comparator: 2 Fexofenadine 120 mg	Drug: Fexofenadine Encapsulated Fexofenadine 120 mg tablets Q.D. Other Names: Allegra
Active Comparator: 3 Cetirizine 10 mg	Drug: Cetirizine Encapsulated Cetirizine 10 mg tablets Q.D. Other Names: Zyrtec
Placebo Comparator: 4 Placebo	Drug: Placebo Encapsulated Placebo tablets Q.D.

Outcome Measures

Primary Outcome Measures

Onset of action and action duration []

Secondary Outcome Measures

Nasal and ocular symptom scores []
Nasal airflow resistance []
Nasal secretion weight []
FEV1 []
Routine safety parameters (vital signs, ECGs, clinical laboratory tests) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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