Clinical Trials Logo
  1. Home
  2. Seasonal Allergic Rhinitis
  3. NCT00574379
  4. Details
NCT00574379 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00574379
Other study ID # BILA 2607/RAE
Secondary ID CTFZ07001
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2007
Est. completion date March 2008

Study information
Verified date February 2019
Source Faes Farma, S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 805
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
• Placebo
Placebo tablets twice daily for 14 days

Locations
Country Name City State
United States Austin Clinical Research Austin Texas
United States Lovelace Scientific Resources Austin Texas
United States MetaClin Research Inc. Austin Texas
United States Kerrville Research Associates Kerrville Texas
United States Oklahoma Allergy and Asthma Clinic Oklahoma City Oklahoma
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 Live Oak Allergy and Asthma San Antonio Texas
United States Southwest Allergy and Asthma Centre San Antonio Texas
United States Sylvana Research Associates San Antonio Texas
United States Allergy & Asthma Care of Waco Waco Texas
United States Allergy Asthma Research Institute Waco Texas

Sponsors (3)
Lead Sponsor Collaborator
Faes Farma, S.A. Allied Research International, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in nasal symptom scores 14 days
Secondary Change in ocular symptom scores and quality of life scores; standard safety assessments 14 days
See also
  Status Clinical Trial Phase
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A