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

Faes Farma

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis; Hypersensitivity; Hay Fever; Seasonal Allergic Rhinitis

Treatments: Drug: Bilastine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574379

CTFZ07001

BILA 2607/RAE

Details and patient eligibility

About

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.

Enrollment: 805 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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805 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

Bilastine 20mg once per day

Treatment:

Drug: Bilastine

2

Experimental group

Description:

Bilastine 20mg twice per day

Treatment:

Drug: Bilastine

3

Experimental group

Description:

Bilastine 10mg once per day

Treatment:

Drug: Bilastine

4

Experimental group

Description:

Bilastine 10mg twice per day

Treatment:

Drug: Bilastine

5

Placebo Comparator group

Treatment:

Drug: Placebo