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)

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis; Hay Fever; Rhinoconjunctivitis
• Intervention / Treatment: Drug: Bilastine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, 905-238-0599
      • Allied Research International - Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Nasal Symptom Scores (TNSS)	within 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	witin 10 days

Collaborators and Investigators

• Sponsor: Faes Farma, S.A.
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 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: Therapeutic Uses; Seasonal Allergic Rhinitis (SAR); Environmental Exposure Chamber (EEC); Antihistamine Drug; Ragweed Pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: BILA 2507/EEC; P2FZ07001