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

Sponsor:	Faes Farma, S.A.
Information provided by:	Faes Farma, S.A.
ClinicalTrials.gov Identifier:	NCT00420082

Purpose

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	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Bilastine Drug: Fexofenadine Drug: Cetirizine Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Fexofenadine Cetirizine Cetirizine hydrochloride Fexofenadine hydrochloride Bilastine

U.S. FDA Resources

Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:

Onset of action and action duration [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nasal and ocular symptom scores [ Designated as safety issue: No ]
Nasal airflow resistance [ Designated as safety issue: No ]
Nasal secretion weight [ Designated as safety issue: No ]
FEV1 [ Designated as safety issue: No ]
Routine safety parameters (vital signs, ECGs, clinical laboratory tests) [ Designated as safety issue: Yes ]

Enrollment:	75
Study Start Date:	October 2006
Study Completion Date:	December 2006

Arms	Assigned Interventions
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 Name: Allegra
Active Comparator: 3 Cetirizine 10 mg	Drug: Cetirizine Encapsulated Cetirizine 10 mg tablets Q.D. Other Name: Zyrtec
Placebo Comparator: 4 Placebo	Drug: Placebo Encapsulated Placebo tablets Q.D.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420082

Locations

Austria
Allergy Center Vienna West
Vienna, Austria, A-1150

Sponsors and Collaborators

Faes Farma, S.A.

Investigators

Principal Investigator:

Friedrich Horak, Professor

ENT University Clinic Vienna

More Information

Publications:

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. 2009 Nov 27; [Epub ahead of print]

Responsible Party:	Dr. Ander Sologuren, Faes Farma
ClinicalTrials.gov Identifier:	NCT00420082 History of Changes
Other Study ID Numbers:	BILA-2306/ACC, 2006-003004-19
Study First Received:	January 8, 2007
Last Updated:	March 5, 2010
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Faes Farma, S.A.:

Rhinitis
Seasonal
Allergic

Pollen allergy
Environmental Exposure Chamber
Challenge Chamber

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fexofenadine
Cetirizine

Terfenadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012