EUCTR2004-004905-11-DE进行中（未招募）不适用
Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma. - AHEAD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,300
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 run-in period, patients must fulfill all of the following criteria
- •at Visit 1:
- •1. Provision of informed consent. The signed and dated informed consent must
- •have been obtained before conducting any study-related procedures, including withdrawal of concomitant medication (consent can be obtained at an information visit or at Visit 1). For patients under-age, signed informed consent from both the
- •patient and the patient’s parent/legal guardian is required.
- •2. Outpatients of either sex, =12 years of age.
- •3. Minimum of 6 months’ documented history of asthma according to the American Thoracic Society definition (ATS 1987).
- •4. Pre-bronchodilatory FEV1 =50% of predicted normal values.
- •5. Reversible airway obstruction (according to reversibility test performed at Visit 1), defined as an increase in FEV1 =12% relative to baseline (for all patients) and for patients =18 years =200 mL after inhalation of in total 1 mg Bricanyl Turbuhaler.
- •6. Prescribed daily use of inhaled GCS for =3 months prior to Visit 1.
- •7. During the last 30 days prior to Visit 1, the daily prescribed dose of inhaled GCS should have been constant and between:
- •- 400-1000 µg metered dose, or the corresponding delivered dose, in combination with LABA
- •- 800-1600 µg metered dose, or the corresponding delivered dose, if used
- •without LABA.
- •8. A history of at least one clinically important asthma exacerbation, as judged by the investigator, between =1 but =12 months prior to Visit 1.
- •To be randomised to the treatment period, the following criteria must be fulfilled at Visit 2:
- •9. Use of as-needed medication on at least 5 of the last 7 days of the run-in period.
- •10. The patient must not have taken more than 8 inhalations of as-needed medication on any day during the run-in period.
- •11. The patient must not have had a clinically important asthma exacerbation, as
- •judged by the investigator, during the run-in period.
- •12. Ability to fill in the diary correctly, and to use peak flow meter, Turbuhaler and
- •Diskus inhalers correctly.
- •13. The patient must still be eligible for the study in accordance with the exclusion criteria.
- •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
- •1. Known or suspected hypersensitivity to active substance or lactose monohydrate.
- •2. Respiratory infection affecting the asthma, as judged by the investigator, within
- •30 days prior to Visit 1.
- •3. Intake of oral, rectal, or parenteral GCS within 30 days prior to Visit 1.
- •4. Use of any ß-blocking agent, including eye-drops.
- •5. A history of smoking =10 pack-years (one pack-year = one 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 (eg, cardiovascular, pulmonary other than
- •asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine,
- •metabolic, malignant, psychiatric, major physical impairment) which, in the
- •opinion of the investigator, either put the patient at risk because of participating
- •in the study or may influence the results of the study, or the patient’s ability to
- •participate in the study.
- •8. Any non-asthma-related clinically significant abnormal finding in physical
- •examination or vital signs at Visit 1, as judged by the investigator.
- •9. Suspected poor capability, as judged by the investigator, to follow instructions of the study, eg, because of a history of alcohol or drug abuse.
- •10. Planned in-patient hospitalisation during the course of the study.
- •11. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational study site).
- •12. Previous allocation of randomisation code in the study.
- •13. Participation in a clinical study during the course of this study or within 30 days prior to Visit 1.
- •14. Inability to tolerate withdrawal of asthma therapy as required for the study.
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma. - AHEADThis is a Phase IIIB study to be performed in adult and adolescent asthmatic patients.Classification code 10003553EUCTR2004-004905-11-ESAstraZeneca AB2,309
招募中
不适用
Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flowbronchial asthma complicated by COPD and bronchial ashtmaJPRN-UMIN000007708Department of respirology, graduate School of Medicine, Chiba University100
已完成
3 期
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mgAsthmaNCT00242775AstraZeneca2,100
已完成
3 期
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in JapanChronic Obstructive Pulmonary DiseaseNCT01070784AstraZeneca328
已完成
不适用
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever TherapyBronchial AsthmaNCT01711840AstraZeneca2,409