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)

NCT ID: NCT00574210

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-02-29

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.

Conditions

Seasonal Allergic Rhinitis; Hay Fever; Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet)

Group Type: EXPERIMENTAL

Bilastine

Intervention Type: DRUG

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

2

Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets)

Group Type: EXPERIMENTAL

Bilastine

Intervention Type: DRUG

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

3

Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet)

Group Type: EXPERIMENTAL

Bilastine

Intervention Type: DRUG

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

4

Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets)

Group Type: EXPERIMENTAL

Bilastine

Intervention Type: DRUG

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

5

Placebo oral twice per day (2 placebo tablets)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Tablets administered twice per day

Interventions

Bilastine

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

Intervention Type: DRUG

Placebo

Placebo Tablets administered twice per day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faes Farma, S.A.

INDUSTRY

Sponsor Role: lead

Allied Research International

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Valiente, MD

Role: STUDY_CHAIR

Faes Farma, S.A.

Piyush Patel, MD

Role: STUDY_DIRECTOR

Allied Research International Inc

Deepen Patel, MD, CCFP

Role: PRINCIPAL_INVESTIGATOR

Allied Research International Inc

Locations

Allied Research International - Cetero Research

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

P2FZ07001

Identifier Type: -

Identifier Source: secondary_id

BILA 2507/EEC

Identifier Type: -

Identifier Source: org_study_id