EUCTR2005-000372-41-GB进行中（未招募）1 期
Real life effectiveness in asthma of Symbicort® Single Inhaler Therapy (RELEASE) - RELEASE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •For inclusion in the study run-in period Subjects must fulfil the following criteria:
- •1.Provision of written informed consent.
- •2.Female or male aged at least 18 years.
- •3.Confirmed diagnosis of asthma (minimum of 6 months documented history prior to visit 1).
- •4.Currently receiving a daily dose of 200 to 1000 µg of BDP or 100 to 500 µg of fluticasone or 200 to 800 µg of budesonide or equivalent for at least 4 weeks.
- •5.Subjects, identified by the investigator, or during routine asthma management, requiring review of their current asthma treatment.
- •6.The Subject needs to be able to read and to be fluent in English.
- •For inclusion in the study treatment period Subjects must fulfil the following criteria:
- •7.At least 1 positive answer on the RCP-3 questionnaire at visit 2.
- •8.No asthma exacerbations during the run-in period (see section 3.3.5.1 for definition of an asthma exacerbation).
- •9.No changes deemed necessary in existing asthma medication during the run-in period.
- •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
排除标准
- •1.Documented history of Chronic Obstructive Pulmonary Disease.
- •2.PEF < 50% of predicted normal value.
- •3.Any non-asthma related, clinically significant abnormal finding in physical examination and/or vital signs at visit 1, which in the opinion of the Investigator, may put the Subject at risk because of his/her participation in the study.
- •4.Use of oral, rectal or parenteral glucocorticosteroids (GCS) 30 days prior to visit 1.
- •5.Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be post-menopausal (at least 1 year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the Investigator.
- •6.Any respiratory tract infection affecting the asthma within 30 days prior to visit 1, as judged by the Investigator.
- •7.Current use of any ß-blocker therapy (including eye drops).
- •8.Any significant disease or disorder (e.g. cardiovascular, pulmonary {other than asthma}, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the Subject at risk because of participation in the study, or may influence the results of the study, or the Subject’s ability to participate in the study.
- •9.Planned in-patient hospitalisation during the course of the study.
- •10.Subjects not considered capable, as judged by the Investigator, of following the instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason.
- •11.Previous enrolment or randomisation of treatment in the present study.
- •12.Subjects who have participated in another clinical study within 90 days of visit 1.
- •13.Known or suspected hypersensitivity to active ingredients of study medication or excipients.
- •14.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
- •15. Smoking, current or previous with a smoking history of more than 10 pack years (one pack year = 1 pack (20 cigarettes) per day for 1 year or equivalent)
研究者
相似试验
已完成
3 期
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