EUCTR2004-004586-14-BE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 790
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* 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? yes
- •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
排除标准
- •* 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.
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