Back to resultsA Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Bilastine
Fexofenadine
Cetirizine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber
Eligibility 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
Sites / Locations
- Allergy Center Vienna West
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Bilastine 20 mg
Fexofenadine 120 mg
Cetirizine 10 mg
Placebo
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420082
Brief Title
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bilastine 20 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fexofenadine 120 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Cetirizine 10 mg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Encapsulated Bilastine 20 mg tablets Q.D.
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Other Intervention Name(s)
Allegra
Intervention Description
Encapsulated Fexofenadine 120 mg tablets Q.D.
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Zyrtec
Intervention Description
Encapsulated Cetirizine 10 mg tablets Q.D.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Encapsulated Placebo tablets Q.D.
Primary Outcome Measure Information:
Title
Onset of action and action duration
Secondary Outcome Measure Information:
Title
Nasal and ocular symptom scores
Title
Nasal airflow resistance
Title
Nasal secretion weight
Title
FEV1
Title
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Horak, Professor
Organizational Affiliation
ENT University Clinic Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Center Vienna West
City
Vienna
ZIP/Postal Code
A-1150
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
19943178
Citation
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. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27.
Results Reference
result
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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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