A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
|ClinicalTrials.gov Identifier: NCT00420082|
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : April 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Bilastine Drug: Fexofenadine Drug: Cetirizine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Completion Date :||December 2006|
Bilastine 20 mg
Encapsulated Bilastine 20 mg tablets Q.D.
Active Comparator: 2
Fexofenadine 120 mg
Encapsulated Fexofenadine 120 mg tablets Q.D.
Other Name: Allegra
Active Comparator: 3
Cetirizine 10 mg
Encapsulated Cetirizine 10 mg tablets Q.D.
Other Name: Zyrtec
Placebo Comparator: 4
Encapsulated Placebo tablets Q.D.
- Onset of action and action duration
- Nasal and ocular symptom scores
- Nasal airflow resistance
- Nasal secretion weight
- Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
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
|Allergy Center Vienna West|
|Vienna, Austria, A-1150|
|Principal Investigator:||Friedrich Horak, Professor||ENT University Clinic Vienna|