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

A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574379

Enrollment

805

Registered

2007-12-17

Start date

2007-12-31

Completion date

2008-03-31

Last updated

2019-02-15

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

Conditions

Allergic Conjunctivitis, Hay Fever, Hypersensitivity, Seasonal Allergic Rhinitis

Keywords

Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis

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.

Interventions

DRUGBilastine

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

DRUGPlacebo

Placebo tablets twice daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in nasal symptom scores	14 days

Secondary

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

Countries

United States

Outcome results

None listed

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