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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420082

Enrollment

Registered

2007-01-09

Start date

2006-10-31

Completion date

2006-12-31

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber

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.

Interventions

DRUGFexofenadine

Encapsulated Fexofenadine 120 mg tablets Q.D.

DRUGCetirizine

Encapsulated Cetirizine 10 mg tablets Q.D.

DRUGPlacebo

Encapsulated Placebo tablets Q.D.

DRUGBilastine

Encapsulated Bilastine 20 mg tablets Q.D.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Onset of action and action duration	—

Secondary

Measure	Time frame
Nasal and ocular symptom scores	—
Nasal airflow resistance	—
Nasal secretion weight	—
FEV1	—
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026