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

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ClinicalTrials.gov Identifier: NCT00420082
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  1. Onset of action and action duration

Secondary Outcome Measures :
  1. Nasal and ocular symptom scores
  2. Nasal airflow resistance
  3. Nasal secretion weight
  4. FEV1
  5. Routine safety parameters (vital signs, ECGs, clinical laboratory tests)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420082


Locations
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Austria
Allergy Center Vienna West
Vienna, Austria, A-1150
Sponsors and Collaborators
Faes Farma, S.A.
Investigators
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Principal Investigator: Friedrich Horak, Professor ENT University Clinic Vienna
More Information
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Publications of Results:

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Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00420082    
Other Study ID Numbers: BILA-2306/ACC
2006-003004-19 ( EudraCT Number )
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012
Keywords provided by Faes Farma, S.A.:
Rhinitis
Seasonal
Allergic
 Pollen allergy
Environmental Exposure Chamber
Challenge Chamber
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Cetirizine
Fexofenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs