Double-blind, randomised, placebo-controlled, phase III study comparing the efficacy and safety of bilastine 20 mg once daily and cetirizine 10 mg for the treatment of allergic allergic rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Registration Number
- EUCTR2004-004586-14-CZ
- Lead Sponsor
- FAES FARMA S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
* Patients of either sex between 12 and 70 years of age.
*Patients with documented clinical history of Seasonal Allergic Rhinitis (SAR), for at least 2 years prior to the study inclusion.
* Positive skin prick test for at least one of the seasonal allergen specific of the geographical area. A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.
* Subjects who have given their informed consent to participate in the study after having received information about the design, aims and potential risks that could result from the study and having been informed that they can refuse to take part in or withdraw from the study at any time.
If the patient is a minor, the informed consent to participate in the study should be signed both by his/her parents or legal tutor/guardian, and the patient, who should be informed according to his/her understanding.
In such cases the local legal requirements relating the inclusion of minors in clinical trials will be followed. (i.e. communication to the Fiscal Ministry following the Spanish requirements)
* Patients willing to attend the required visits scheduled in the protocol, and filling the diary card provided.
* Patients with positive symptoms. To be included (D0), the patients must have a sum in the previous 6 assessments (or previous 3 days, if the patients do not evaluate the morning before the visit) of the nasal symptoms score equal to or greater than 36 in the assessment of the reflective symptoms.
In addition, to be included the patient must have on D0 a score of nasal symptoms equal to or greater than 6, on the inclusion visit, on the instantaneous symptoms.
* Presence of high to very high values on the specific pollen count in each site.
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) yes
F.1.3.1 Number of subjects for this age range
* Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.)
* Negative skin prick test
* Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months.
* Any other nasal illness that can interfere with the aim of the study.
* Patients who have acute or chronic sinusitis as judged by the investigator.
* Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
* Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period
Note: These wash-out periods should refer to the randomisation date.
- Systemic, inhaled or intranasal corticosteroids: 4 weeks.
- Antihistamines: Loratadine (10 days), desloratadine (10 days) other systemic or intranasal antihistamines (3 days).
- Anti-leukotrienes.
- Delayed-release corticosteroids (3 months).
- Ketotifen (2 weeks).
- Macrolides antibiotics and imidazolic antifungals (systemic)
- H2 antihistamines.
- Anticholinergics.
- Drugs with antihistamine properties (phenothiazine).
- Sodium chromoglycate, nedocromil. (2 weeks).
- Intranasal and systemic decongestants (3 days)
- Lodoxamine
* Hypersensitivity to H1 antihistamines, benzimidazoles, or lactose.
*Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmia, recent acute myocardial infarction or neoplastic diseases.
* Pregnant or breast-feeding women. Women who could potentially become pregnant must use an effective birth control method (oral contraceptives, intrauterine device, condom or diaphragm). The patient’s agreement to use it will be considered sufficient for participation in the study.
* Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
* Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study or patients unable to sign the informed consent form
* Patients unable to comply with the study requirements or unable to complete the patient diary and take the study treatment.
* Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
* Patients whose health could be harmed by their participation in the study.
* Patients who are currently participating in or have participated in another clinical trial within the last three months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of bilastine 20 mg, compared to Cetirizine and placebo for the symptomatic treatment of seasonal allergic rhinitis.;Secondary Objective: - To assess the overall efficacy of Bilastine against nasal and non-nasal symptoms associated with seasonal allergic rhinitis compared to Cetirizine.<br>- Overall assessment by the investigator at the end of treatment using the Global Clinical Impression scale.<br>- Evaluation of the tolerability of each study drug by assessment of:<br>*Adverse events<br>*Biological safety by performing two blood tests (hematology and biochemistry) before and after treatment. <br>*Cardiologic safety by performing an ECG before and after treatment.<br>;Primary end point(s): Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient’s assessment on reflective symptoms.
- Secondary Outcome Measures
Name Time Method