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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00420082
First received: January 8, 2007
Last updated: April 4, 2012
Last verified: April 2012

January 8, 2007
April 4, 2012
October 2006
Not Provided
Onset of action and action duration [ Designated as safety issue: No ]
Onset of action
Complete list of historical versions of study NCT00420082 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Nasal and ocular symptom scores
  • Nasal airflow resistance
  • Nasal secretion weight
  • FEV1
  • Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
Not Provided
Not Provided
 
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Bilastine
    Encapsulated Bilastine 20 mg tablets Q.D.
  • Drug: Fexofenadine
    Encapsulated Fexofenadine 120 mg tablets Q.D.
    Other Name: Allegra
  • Drug: Cetirizine
    Encapsulated Cetirizine 10 mg tablets Q.D.
    Other Name: Zyrtec
  • Drug: Placebo
    Encapsulated Placebo tablets Q.D.
  • Experimental: 1
    Bilastine 20 mg
    Intervention: Drug: Bilastine
  • Active Comparator: 2
    Fexofenadine 120 mg
    Intervention: Drug: Fexofenadine
  • Active Comparator: 3
    Cetirizine 10 mg
    Intervention: Drug: Cetirizine
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2006
Not Provided

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00420082
BILA-2306/ACC, 2006-003004-19
No
Faes Farma, S.A.
Faes Farma, S.A.
Not Provided
Principal Investigator: Friedrich Horak, Professor ENT University Clinic Vienna
Faes Farma, S.A.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP