Allergic Rhinitis MedDRA version: 14.0 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Bilaxten 20 mg, comprimidos
Product Name: Bilastina
Pharmaceutical Form: Tablet
INN or Proposed INN: Bilastina
CAS Number: 202189-78-4
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18 and 70 years. 2. Documented medical records of pollen-induce rhinitis at least two years preceding the screening visit. 3. Skin tests and/or positive specific IgE determination for some inhalant allergen/s. 4. Written informed consent that is consistent with ICH-GCP guidelines. 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Allergic rhinitis symptoms presence. 2. Any type of physical abnormality (nasal septum deviation, recent nasal surgery, etc.), which could interfere with the study objectives. 3. Bilastine or any of its excipients hypersensitivity. 4. Use of any intranasal medication. 5. Patients on oral or systemic treatment for allergic rhinitis that will not complied with the following washout periods prior to their inclusion in the study: - depot corticosteroids (3 months), systemic or topical (4 weeks). - Antihistamine drugs: astemizole (6 weeks), elastin, loratadine and desloratadine (10 days), other systemic antihistamine drugs (3 days). - Antileukotriene drugs (3 days) - Ketotifen (2 weeks) - Drugs with antihistaminic properties (phenothiazine) - Cromoglicic acid, nedocromil (2 weeks) For treatments that don't specify a washout period in parentheses, it's enough to stop the treatment the day of inclusion in the trial. 6. History of non-allergic rhinitis (vasomotor, infectious, drug induced, etc.). 7. Chronic sinusitis or severe bronchial asthma. 8. Respiratory infection within 30 days before the start of the study. 9. Concomitant serious disease that could interfere with response to treatment (hepatic, renal, cardiovascular) or malignancy. 10. Patients with mental illness that prevents the subject understand the nature, purpose and implications of the study or patients who are unable to sign informed consent. 11. Patients with known unresponsiveness to H1 antihistamine drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effects of Bilastine on nasal obstruction in allergic rhinitis patients after nasal provocation with allergen.;Secondary Objective: Assess the effects of bilastine on nasal symptomatology evaluated by a symptoms score and by a visual analog scale after nasal provocation with allergen.;Primary end point(s): Parameters to be evaluated by acoustic rhinometry are: a) nasal volume from 2-7 cm. from narine in both nostrils and b) the minimum transverse area (ATM) from 1 cm. from the narine.;Timepoint(s) of evaluation of this end point: Basal, at 15, 30 and 60 minutes after nasal provocation with an allergen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the clinical response will be done by the patient taking into account the intensity of the following nasal symptoms: rhinorrhea, itching, obstruction and sneezing.;Timepoint(s) of evaluation of this end point: Basal, at 15, 30 and 60 minutes after nasal provocation with an allergen. | — |
Countries
Spain
Contacts
Public ContactUnitat d'Al.lèrgia
Hospital Clinic i Provincial de Barcelona
Outcome results
None listed