Seasonal Allergic Rhinitis MedDRA version: 8.1 Level: LLT Classification code 10039083 Term: Rhinitis
Conditions
Interventions
Product Name: Bilastine
Pharmaceutical Form: Tablet
CAS Number: 202189-78-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo:
Sponsors
FAES Farma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. - They are aged 18 to 55 years inclusive. - They have a history of seasonal allergic rhinitis (SAR). - They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom score of at least 6. (Nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which have been scored on a scale from 0 to 3). - They will not have reduced symptoms (>2 symptom scoring points from the qualification score) after a single dose of placebo at the last scoring in the following hour of the qualifying session. - They have a positive skin prick test (wheal ? 3mm) for grass pollen at or within the 12 months preceding the screening visit. - They have a positive RAST (? class 2) for grass pollen at or within the 12 months preceding the screening visit. - There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. - They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. - They are available to complete all study measurements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). - On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study. - Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function. - The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. - The subject has participated in any clinical study in the previous month. - The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. - Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). - The subject is at risk of non-compliance with the study procedures/restrictions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate effect of single dose of Bilastine 20mg vs. placebo on TNSS (total nasal symptom score) of allergic rhinitis provoked by spending 4h in the VCC after dosing on day 1.;Secondary Objective: Investigate effect of single dose of Bilastine 20mg vs. Cetirizine 10mg and Fexofenadine 120mg on TNSS (total nasal symptom score) of allergic rhinitis provoked by spending 4h in the VCC after dosing on day 1. Explore effects of single dose of Bilastine 20mg compared to Cetrizine 10mg, Fexofenadine 120mg and placebo on nasal, eye and other symptoms, nasal obstruction (anterior rhinomanometry) and secretions in allergic rhinitis provoked by spending 4h in the VCC post-dose on day 1. Explore effects of single dose of Bilastine 20mg compared to Cetrizine 10mg, Fexofenadine 120mg and placebo on nasal, eye and other symptoms, nasal obstruction (anterior rhinomanometry) and secretions in allergic rhinitis provoked by spending 4h in the VCC on day 2 (22 – 26h post-dose day 1), as a measure of persistent drug activity. ;Primary end point(s): Weighted mean total nasal symptom score (TNSS) (nasal obstruction, rhinorrhoea, itchy nose and sneezing) 0-4h post-dose period spent in the VCC on day 1. | — |
Countries
Austria
Outcome results
None listed