EUCTR2007-002722-29-HU进行中（未招募）不适用
A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort (budesonide/formoterol) HFA pMDI 40/2.25ug twice daily, with and without spacer, in children (6-11 years) with asthma - SPACER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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 enrolment in the study patients must fulfil all of the following criteria at Visit 1:
- •1.Out-patients of either sex, 6 - 11 years
- •2.Signed Informed Consent from both the patient and the patient’s parent/legal guardian must be obtained prior to any study-related procedures. If the patient cannot read and write, oral consent from the patient is required.
- •For inclusion in the study run-in period patients must fulfil all of the following criteria at Visit 2:
- •3.Asthma diagnosed according to the American Thoracic Society (ATS) definition at least 6 months prior to Visit 2.
- •4.PEF ³ 50 % of predicted normal values (pre-bronchodilator)
- •5.Daily use of inhaled glucocorticosteroids (GCS of any brand) for =3 months prior to Visit 2
- •6.During 30 days prior to Visit 2, the dose of any brand of inhaled GCS should have been constant and within the range of 375- 800 µg.
- •7.Ability to use pMDI, spacer, and peak flow meter correctly
- •For randomization into the study patients must fulfil all of the following criteria at visit 3:
- •8.Run-in diary data for mPEF recorded on at least 7 (any 7) of the last 10 days of the run-in period (including the morning of the first day of Visit 3)
- •9.A mean mPEF during the last 7 days of the run-in period (including the value obtained in the morning of the first day of Visit 3) of 50 to 85% of post-bronchodilatory PEF obtained after administration of inhaled terbutaline sulphate (Bricanyl Turbuhaler; 2 x 0.5 mg/inhalation) at Visit 2 or 3.
- •10.Total asthma symptom score (night-time plus daytime) of =1 on at least 4 of the last 7 days of the run-in period (not including the recording in the morning of the first day of Visit 3).
- •11.No change in asthma treatment during the run-in period
- •12.A successful baseline urine collection, as judged by the investigator, before randomization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •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.Use of oral, parenteral, or rectal GCSs within 30 days prior to Visit 2
- •2.Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to Visit 2.
- •3.Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patients ability to participate in the study.
- •4.Known or suspected hypersensitivity to study therapy or excipents of the investigational products.
- •5.Current use of any ß2-blocker therapy, including eye-drops.
- •6.Planned hospitalisation during the study.
- •7.Any clinically relevant abnormal findings in physical examination, vital signs, or urinalysis at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
- •8.When applicable, girls of childbearing potential who are not using acceptable contraceptives, as judged by the investigator.
- •9.Conditions associated with poor compliance.
- •10.Participation in another clinical study of any investigational drug 30 days prior to or during this study.
- •11.Previously randomized into the study.
- •12.Patient’s parent/legal guardian should not be involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
研究者
相似试验
进行中（未招募）
不适用
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology (ALFACHIP)EUCTR2014-004659-30-Outside-EU/EEAsanofi-aventis24
进行中（未招募）
不适用
Clinical study to evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel in subjects with knee osteoarthritisMedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859Knee osteoarthritisEUCTR2012-004024-38-DEovartis Consumer Health S.A.
进行中（未招募）
不适用
A 54-week, randomized, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential hypertensioHypertensionEUCTR2006-003629-98-DEovartis Pharma Services AG500
进行中（未招募）
不适用
A 54-week, randomized, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential hypertensioMedDRA version: 8.1Level: LLTClassification code 10020772Term: HypertensionHypertensionEUCTR2006-003629-98-FIovartis Pharma AG500
进行中（未招募）
不适用
A 54-week, randomized, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential hypertensioHypertensionEUCTR2006-003629-98-BEovartis Pharma AG500