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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Faes Farma, S.A.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Onset of action and action duration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Bilastine 20 mg
Intervention: Bilastine (Drug)
2
Fexofenadine 120 mg
Intervention: Fexofenadine (Drug)
3
Cetirizine 10 mg
Intervention: Cetirizine (Drug)
4
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Onset of action and action duration
Secondary Outcomes
- Nasal and ocular symptom scores
- Nasal airflow resistance
- Nasal secretion weight
- FEV1
- Routine safety parameters (vital signs, ECGs, clinical laboratory tests)