NCT00420082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

First QC Date

January 8, 2007

Last Update Submit

April 4, 2012

Conditions

Seasonal Allergic Rhinitis

Keywords

RhinitisSeasonalAllergicPollen allergyEnvironmental Exposure ChamberChallenge Chamber

Outcome Measures

Primary Outcomes (1)

  • Onset of action and action duration

Secondary Outcomes (5)

  • Nasal and ocular symptom scores

  • Nasal airflow resistance

  • Nasal secretion weight

  • FEV1

  • Routine safety parameters (vital signs, ECGs, clinical laboratory tests)

Study Arms (4)

1

EXPERIMENTAL

Bilastine 20 mg

Drug: Bilastine

2

ACTIVE COMPARATOR

Fexofenadine 120 mg

Drug: Fexofenadine

3

ACTIVE COMPARATOR

Cetirizine 10 mg

Drug: Cetirizine

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BilastineDRUG

Encapsulated Bilastine 20 mg tablets Q.D.

1
FexofenadineDRUG

Encapsulated Fexofenadine 120 mg tablets Q.D.

Also known as: Allegra
2
CetirizineDRUG

Encapsulated Cetirizine 10 mg tablets Q.D.

Also known as: Zyrtec
3
PlaceboDRUG

Encapsulated Placebo tablets Q.D.

4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Have a clinically significant illness or disease
  • Have unstable asthma
  • Has participated in a clinical trial 30 days prior to the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Center Vienna West

Vienna, A-1150, Austria

Location

Related Publications (1)

  • 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.

    PMID: 19943178RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis

Interventions

bilastinefexofenadineCetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Friedrich Horak, Professor

    ENT University Clinic Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

October 1, 2006

Study Completion

December 1, 2006

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

AU(1)