NCT00574210

PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

A Randomized, Double-blind, Placebo-controlled, 5-arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.

Conditions

• Seasonal Allergic Rhinitis
• Hay Fever
• Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Bilastine	Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
DRUG	Placebo	Placebo Tablets administered twice per day

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-12-17
• Last updated: 2019-02-15

Locations

1 site across 1 country: Canada