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

Completed · Phase 2 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis, Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00574379

Run by

Faes Farma, S.A.

People needed

805

Starts

2007-12-01

Expected to finish

2008-03-01

Last updated by the study team

2019-02-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Oklahoma Allergy and Asthma Clinic — Oklahoma City, Oklahoma, United States
• MetaClin Research Inc. — Austin, Texas, United States
• Austin Clinical Research — Austin, Texas, United States
• Lovelace Scientific Resources — Austin, Texas, United States
• Kerrville Research Associates — Kerrville, Texas, United States
• Biogenics Research Institute — San Antonio, Texas, United States
• DGD Research — San Antonio, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• Southwest Allergy and Asthma Centre — San Antonio, Texas, United States
• Sylvana Research Associates — San Antonio, Texas, United States
• Live Oak Allergy and Asthma — San Antonio, Texas, United States
• Allergy & Asthma Care of Waco — Waco, Texas, United States
• Allergy Asthma Research Institute — Waco, Texas, United States

Full record on ClinicalTrials.gov

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