EUCTR2013-002523-42-ES进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel group, placebo-controlled, Phase 3 efficacy and safety study of benralizumab (MEDI-563) to reduce oral corticosteroid use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus long acting beta2 agonist and chronic oral corticosteroid therapy (ZONDA) - ZONDA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •1.Provision of informed consent prior to any study specific procedures
- •2. Female and male aged from 18 to 75 years, inclusively
- •3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and a
- •4. Elevated level of peripheral blood eosinophil
- •5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1
- •6. Chronic oral prednisone or prednisolone therapy for at least 6 continuous months
- •directly preceding Visit 1, and on a stable dose for at least one month prior to Visit 1
- •7.Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in.
- •8. Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted
- •9. Either documented post bronchodilator (post-BD) reversibility of > o = 12% and > o = 200 mL in FEV1 or PC20 FEV1
- •10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
- •11. Optimized OCS dose reached at least 2 weeks prior to randomization
- •12. Additional asthma controller medication must not have been initiated during run-in
- •13. At least 70% compliance with OCS use
- •14. At least 70% compliance with usual asthma controller ICS-LABA
- •15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning
- •and evening diary)
- •16. No documented asthma exacerbations during the screening/dose optimization 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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
- •2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological,musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •- Affect the safety of the patient throughout the study
- •- Influence the findings of the studies or their interpretations
- •- Impede the patient?s ability to complete the entire duration of study
- •3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- •4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in
- •the study, or may influence the results of the study, or the patient?s ability to complete entire duration of the study
- •5. History of life-threatening asthma
- •6. Asthma control reached at an OCS dose of < o = 5mg during
- •run-in/OCS optimization phase
- •7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5
- •8. Receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
研究者
相似试验
已完成
3 期
A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV)10019280Chronic heart failureNL-OMON39821ovartis150
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of LCZ969 in heart failure patients with preserved ejection fraction.EUCTR2013-001747-31-ITOVARTIS FARMA S.p.A.4,822
已完成
2 期
A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis2024-511706-23-00Boehringer Ingelheim International GmbH31
招募中
3 期
Study of efficacy and safety of iptacopan in patients with C3 glomerulopathyCTRI/2021/10/037351ovartis Healthcare Pvt Ltd
招募中
3 期
Study of efficacy and safety of iptacopan in participants with IC-MPGJPRN-jRCT2031230365Hirano Takamitsu68