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

February 13, 2019 updated by: Faes Farma, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

805

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Allergy and Asthma Clinic
    • Texas
      • Austin, Texas, United States, 78704
        • MetaClin Research Inc.
      • Austin, Texas, United States, 78750
        • Austin Clinical Research
      • Austin, Texas, United States, 78759
        • Lovelace Scientific Resources
      • Kerrville, Texas, United States, 78028-6071
        • Kerrville Research Associates
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • San Antonio, Texas, United States, 78229
        • Biogenics Research Institute
      • San Antonio, Texas, United States, 78229
        • DGD Research
      • San Antonio, Texas, United States, 78229
        • Southwest Allergy and Asthma Centre
      • San Antonio, Texas, United States, 78229
        • Sylvana Research Associates
      • San Antonio, Texas, United States, 78233
        • Live Oak Allergy and Asthma
      • Waco, Texas, United States, 76708
        • Allergy & Asthma Care of Waco
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bilastine 20mg once per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 2
Bilastine 20mg twice per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 3
Bilastine 10mg once per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 4
Bilastine 10mg twice per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Placebo Comparator: 5
Drug: Placebo
Placebo tablets twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in nasal symptom scores
Time Frame: 14 days
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Collaborators

Merck Sharp & Dohme LLC
Allied Research International

Investigators

  • Study Director: Ander Sologuren, MD, Faes Farma, S.A.
  • Principal Investigator: Paul Ratner, MD, Sylvana Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILA 2607/RAE
  • CTFZ07001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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