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)

Sponsor

Faes Farma, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00574210

Collaborator

Allied Research International (Industry)

502

Enrollment

Location

Arms

Duration (Months)

124.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis Hay Fever Rhinoconjunctivitis	Drug: Bilastine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

502 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Total Nasal Symptom Scores (TNSS) [within 10 days]

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) [witin 10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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