Clinical trial NCT00574210: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Hay Fever
Rhinoconjunctivitis
Keywords: Seasonal Allergic Rhinitis (SAR)
Environmental Exposure Chamber (EEC)
Therapeutic Uses
Antihistamine Drug
Ragweed Pollen
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allied Research International
First posted: 2007-12-17
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total Nasal Symptom Scores (TNSS)
timeFrame: within 10 days
Secondary outcomes:
measure: 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)
timeFrame: witin 10 days
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Allied Research International - Cetero Research
state: Ontario
Study officials:
affiliation: Faes Farma, S.A.
name: Roman Valiente, MD
role: STUDY_CHAIR
affiliation: Allied Research International Inc
name: Piyush Patel, MD
role: STUDY_DIRECTOR
affiliation: Allied Research International Inc
name: Deepen Patel, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References: