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)

NCT00574210 | Completed Phase 2 DMC

• 2 other identifiers: BILA 2507/EECP2FZ07001
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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

Keywords

Seasonal Allergic Rhinitis (SAR); Environmental Exposure Chamber (EEC); Therapeutic Uses; Antihistamine Drug; Ragweed Pollen

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Scores (TNSS)

  within 10 days

Secondary Outcomes (1)

• 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

Study Arms (5)

1

EXPERIMENTAL

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

Drug: Bilastine

2

EXPERIMENTAL

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

Drug: Bilastine

3

EXPERIMENTAL

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

Drug: Bilastine

4

EXPERIMENTAL

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

Drug: Bilastine

5

PLACEBO COMPARATOR

Placebo oral twice per day (2 placebo tablets)

Drug: Placebo

Interventions

Bilastine DRUG

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

1; 2; 3; 4

Placebo DRUG

Placebo Tablets administered twice per day

5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faes Farma, S.A.: lead
• Allied Research International: collaborator

Study Sites (1)

Allied Research International - Cetero Research

Mississauga, Ontario, 905-238-0599, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

bilastine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Roman Valiente, MD

  Faes Farma, S.A.

  STUDY CHAIR

• Piyush Patel, MD

  Allied Research International Inc

  STUDY DIRECTOR

• Deepen Patel, MD, CCFP

  Allied Research International Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CA (1)