Back to resultsPK/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)
Primary Purpose
Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bilastine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal Allergic Rhinitis (SAR), Environmental Exposure Chamber (EEC), Therapeutic Uses, Antihistamine Drug, Ragweed Pollen
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.
Sites / Locations
- Allied Research International - Cetero Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
5
Arm Description
Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet)
Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets)
Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet)
Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets)
Placebo oral twice per day (2 placebo tablets)
Outcomes
Primary Outcome Measures
Total Nasal Symptom Scores (TNSS)
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)
Full Information
NCT ID
NCT00574210
First Posted
December 14, 2007
Last Updated
February 13, 2019
Sponsor
Faes Farma, S.A.
Collaborators
Allied Research International
1. Study Identification
Unique Protocol Identification Number
NCT00574210
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.
Collaborators
Allied Research International
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis
Keywords
Seasonal Allergic Rhinitis (SAR), Environmental Exposure Chamber (EEC), Therapeutic Uses, Antihistamine Drug, Ragweed Pollen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet)
Arm Title
2
Arm Type
Experimental
Arm Description
Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets)
Arm Title
3
Arm Type
Experimental
Arm Description
Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet)
Arm Title
4
Arm Type
Experimental
Arm Description
Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets)
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
Placebo oral twice per day (2 placebo tablets)
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tablets administered twice per day
Primary Outcome Measure Information:
Title
Total Nasal Symptom Scores (TNSS)
Time Frame
within 10 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Valiente, MD
Organizational Affiliation
Faes Farma, S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Piyush Patel, MD
Organizational Affiliation
Allied Research International Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deepen Patel, MD, CCFP
Organizational Affiliation
Allied Research International Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Research International - Cetero Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
905-238-0599
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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)
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