Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Phase 2

Completed

• Conditions: Hay Fever; Allergic Conjunctivitis; Hypersensitivity; Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Bilastine

• Registration Number: NCT00574379
• Lead Sponsor: Faes Farma, S.A.

Brief Summary

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

Inclusion Criteria

• clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
• documentation of a positive skin test within one year of screening to Mountain Cedar allergen

Exclusion Criteria

• significant medical condition
• significant nasal abnormality
• significant cardiac condition
• recent infection
• use of other allergy medication during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5	Placebo	-
3	Bilastine	Bilastine 10mg once per day
2	Bilastine	Bilastine 20mg twice per day
1	Bilastine	Bilastine 20mg once per day
4	Bilastine	Bilastine 10mg twice per day

Primary Outcome Measures

Name	Time	Method
Change in nasal symptom scores	14 days

Secondary Outcome Measures

Name	Time	Method
Change in ocular symptom scores and quality of life scores; standard safety assessments	14 days

Trial Locations

Locations (13)

Lovelace Scientific Resources; 🇺🇸 Austin, Texas, United States

Live Oak Allergy and Asthma; 🇺🇸 San Antonio, Texas, United States

MetaClin Research Inc.; 🇺🇸 Austin, Texas, United States

Oklahoma Allergy and Asthma Clinic; 🇺🇸 Oklahoma City, Oklahoma, United States

Austin Clinical Research; 🇺🇸 Austin, Texas, United States

Biogenics Research Institute; 🇺🇸 San Antonio, Texas, United States

Kerrville Research Associates; 🇺🇸 Kerrville, Texas, United States

Diagnostics Research Group; 🇺🇸 San Antonio, Texas, United States

Sylvana Research Associates; 🇺🇸 San Antonio, Texas, United States

DGD Research; 🇺🇸 San Antonio, Texas, United States

Southwest Allergy and Asthma Centre; 🇺🇸 San Antonio, Texas, United States

Allergy & Asthma Care of Waco; 🇺🇸 Waco, Texas, United States

Allergy Asthma Research Institute; 🇺🇸 Waco, Texas, United States