EUCTR2005-000532-25-CZ进行中（未招募）1 期
A comparison of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 mcg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults - a 26-week, randomised, open-label, parallel-group, multicentre study - STYLE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 995
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
- •For inclusion in the study patients must fulfil all of the following criteria at Visit 1:
- •1.Signed informed consent form. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained.
- •2.Female or male outpatients aged 12 years and older*.
- •3.Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
- •4.Ability to read and write in the local language.
- •5.Prescribed inhaled GCS at a dose of 320 µg or more per day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
- •- daily maintenance treatment with both inhaled GCS and long-acting Beta2-agonist (LABA)
- •- daily treatment with inhaled GCS alone (i.e. without LABA) and a history of suboptimal asthma control the month prior to enrolment as judged by the investigator
- •and use of 3 or more inhalations of as needed medication for symptom relief during the last 7 days before enrolment.
- •* In some countries aged 18 years and older.
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1.Previous treatment with Symbicort Single inhaler Therapy (use of Symbicort Turbuhaler for both maintenance treatment and as needed).
- •2.Use of any Beta-blocking agent, including eye-drops.
- •3.Use of oral GCS as maintenance treatment for any indication.
- •4.Known or suspected hypersensitivity to study therapy or excipients.
- •5.A history of smoking 10 or more pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
- •6.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
- •7.Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study.
- •8.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 patient at risk because of his/her participation in the study.
- •9.Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
- •10.Planned in-patient hospitalisation during the course of the study.
- •11.Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficulty in reading and/or understand instructions or any other reason, as judged by the investigator.
- •12.Previous allocation of randomisation code in this study.
- •13.Participating in another clinical trial during the course of this study or within 30 days prior to Visit 1.
- •14.Involvement in the planning or conduct of this study.
研究者
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