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)

This study has been completed.
Sponsor:
Collaborator:
Allied Research International
Information provided by:
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00574210
First received: December 14, 2007
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Hay Fever
Rhinoconjunctivitis
Drug: Bilastine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 5-Arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode

Resource links provided by NLM:


Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • Total Nasal Symptom Scores (TNSS) [ Time Frame: within 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC) [ Time Frame: witin 10 days ] [ Designated as safety issue: No ]

Enrollment: 502
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet)
Drug: Bilastine
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Experimental: 2
Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets)
Drug: Bilastine
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Experimental: 3
Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet)
Drug: Bilastine
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Experimental: 4
Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets)
Drug: Bilastine
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Placebo Comparator: 5
Placebo oral twice per day (2 placebo tablets)
Drug: Placebo
Placebo Tablets administered twice per day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical history of SAR for the last two ragweed allergy seasons.
  • A positive skin test within 12 months of screening to ragweed allergen.
  • A minimum qualifying symptom score on both Visits, 2 and 3.
  • Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.

Exclusion Criteria:

  • Women who are pregnant, breastfeeding, or planning a pregnancy.
  • History of more than mild asthma.
  • History of clinically significant (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
  • Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
  • An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
  • A need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
  • Currently taking monoamine oxidase (MAO) inhibitors.
  • Taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to Visit 1.
  • Taken any antihistamine within seven days prior to Visit 1 skin testing.
  • Known current alcohol or drug abuse.
  • Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - History of generalized anaphylaxis requiring medical attention.
  • Clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574210

Locations
Canada, Ontario
Allied Research International - Cetero Research
Mississauga, Ontario, Canada, 905-238-0599
Sponsors and Collaborators
Faes Farma, S.A.
Allied Research International
Investigators
Study Chair: Roman Valiente, MD Faes Farma, S.A.
Study Director: Piyush Patel, MD Allied Research International Inc
Principal Investigator: Deepen Patel, MD, CCFP Allied Research International Inc
  More Information

No publications provided

Responsible Party: Ander Sologuren, MD, Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00574210     History of Changes
Other Study ID Numbers: BILA 2507/EEC, P2FZ07001
Study First Received: December 14, 2007
Last Updated: January 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by Faes Farma, S.A.:
Seasonal Allergic Rhinitis (SAR)
Environmental Exposure Chamber (EEC)
Therapeutic Uses
Antihistamine Drug
Ragweed Pollen

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014