EUCTR2017-002483-40-PL进行中（未招募）1 期
A Phase 2b Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi Centre Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD7594 DPI Given Once Daily for twelve weeks, compared to placebo, in Asthmatics symptomatic on low dose ICS - GRANIT
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
- 714
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. Men and women 18 to 85 years of age, inclusive
- •3. Patients need to be non-smokers or ex-smokers (have quit e-cigarettes or other inhaled tobacco products =6 months before Visit 1) with a total smoking history of less than 10 pack-years (not applicable for e-cigarettes)
- •4. Documented clinical diagnosis of asthma for =6 months before Visit 1
- •5. Patients on stable medium to high dose ICS (equivalent of budesonide >400 µg/day) or low to medium dose ICS/LABA for at least 4 weeks prior to screening (Visit 1).
- •6. Patients must demonstrate reversibility to inhaled bronchodilators at Visit 2 (a =12% and =200 mL improvement in FEV1 after administration of a 4 puffs of salbutamol/albuterol)
- •7. Pre-bronchodilator FEV1 at Visit 3 between 40% and 90% predicted
- •8. At Visit 3, patients need to be symptomatic on low dose ICS as evidenced by combined daily asthma mean symptom score of >1 over the previous 7 days or SABA use on =3 of the last 7 days during the Run-in Period
- •9. Demonstrate the ability to use the study inhalation device properly
- •10. Patient able to perform acceptable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society (ATS/ERS) acceptability criteria.
- •11. Patient is willing and able to follow study procedures and restrictions. Women of child bearing potential (WOCBP) should be stable on their chosen method of highly effective birth control for a minimum of 3 months prior to Visit 1, and willing to use that for the entire duration of the study (from the time they sign the informed consent), and for 1 month after the last dose of IP
- •12. For optional inclusion in the Gx component of the study, patients must provide separate informed consent for the genomic sampling and analysis
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •1. Known or suspected hypersensitivity to any of the IPs, including budesonide, or excipients, including lactose
- •2. Systemic steroid use within the 6 weeks before Visit 1
- •3. Concomitant chronic respiratory disease
- •4. History or clinical suspicion of any clinically relevant or active 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 results or the patient’s ability to participate in the study, or any other safety concerns in the opinion of the Investigator
- •5. Use of prohibited medications that cannot be stopped during the entire period of the study (starting Visit 1).
- •6. Patients with <80% eDiary compliance during Run in Period at Visit 3
- •7. ACQ-5 of =3 at Visit 1, Visit 2, or Visit 3
- •8. Daily rescue use of SABA =12 puffs for =3 consecutive days at any time during Run-in Period, before randomisation.
- •9. Any clinically important abnormalities in rhythm, conduction or morphology of the digital ECG at rest and any abnormalities in the digital ECG (at Visit 1 or Visit 3) that, as considered by the Investigator, may interfere with the interpretation of QT interval corrected (QTc) interval changes
- •10. Prolonged QT interval corrected using Fridericia’s formula (QTcF) =450 msec based on ECG at Visit 1 or Visit 3; or family history of long QT syndrome
- •11. PR (PQ) interval prolongation (>240 msec), intermittent second or third degree atrial-ventricular (AV) block or AV dissociation at Visit 1 or Visit 3
- •12. Patients with implantable cardiac defibrillator and patients with sustained symptomatic ventricular and/or atrial tachyarrhythmia
- •13. Patients with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society Class II, or a myocardial infarction or stroke within 6 months before Visit 1
- •14. History of hospitalisation within 12 months before Visit 1 caused by heart failure or a diagnosis of heart failure higher than New York Heart Association Class II
- •15. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) at Visit 1
- •16. Donation of blood (= 450 mL) within 3 months or donation of plasma within 14 days before Visit 1
- •17. Suspected poor capability to follow instructions of the study, as judged by the Investigator
- •18. Previous participation or prior screen failure in the current study, or participation in any other research study within 1 month prior to Visit 1
- •19. Patient under treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5 half-lives before Visit 1, whichever is longer
- •20. Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1
- •21. History of or current alcohol or drug abuse (including marijuana), as judged by the Investigator
- •22. Planned in-patient surgery, major dental procedure or hospitalisation during the study
- •23. Pregnant woman or lactating woman
- •24. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, contract research organisation staff and/or staff at the study centre)
- •25. Suspicion of Gilbert’s syndrome
- •26. Vulnerable persons (eg, persons kept in detention)
- •Exclusion criteria for the pharmacogenomic part of the study:
- •Previous allogeneic bone marrow transplant.
- •Non-leuk
研究者
相似试验
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of AZD7594 DPI administered once daily via inhalation over twelve weeks of treatment in asthmatics who are symptomatic on low doses of inhaled corticosteroids compared to patients given placebo. The study will evaluate the efficacy of AZD7594 DPI, how this study drug is absorbed in the blood stream, how safe and tolerable it is for the patients and which doses should be considered as optimal for further investigation.AsthmaEUCTR2017-002483-40-BGAstraZeneca AB714
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of AZD7594 DPI administered once daily via inhalation over twelve weeks of treatment in asthmatics who are symptomatic on low doses of inhaled corticosteroids compared to patients given placebo. The study will evaluate the efficacy of AZD7594 DPI, how this study drug is absorbed in the blood stream, how safe and tolerable it is for the patients and which doses should be considered as optimal for further investigation.MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855AsthmaEUCTR2017-002483-40-DEAstraZeneca AB714
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of AZD7594 DPI administered once daily via inhalation over twelve weeks of treatment in asthmatics who are symptomatic on low doses of inhaled corticosteroids compared to patients given placebo. The study will evaluate the efficacy of AZD7594 DPI, how this study drug is absorbed in the blood stream, how safe and tolerable it is for the patients and which doses should be considered as optimal for further investigation.AsthmaEUCTR2017-002483-40-HUAstraZeneca AB714
招募中
1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid ArthritisModerate to Severe Rheumatoid ArthritisMedDRA version: 20.0Level: HLTClassification code: 10039075Term: Rheumatoid arthritis and associated conditions Class: 10021428MedDRA version: 23.1Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859CTIS2023-504564-42-00Anaptysbio Inc.420
进行中（未招募）
1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic PatientsEstudio fase II, randomizado, doble ciego, controlado con placebo, de escalonamiento de dosis para evaluar la seguridad y los efectos de Conivaptan intravenoso sobre la respuesta hemodinámica hepática en pacientes cirróticos euvolémicos o hipervolémicos estables.stable euvolemic or hypervolemic cirrhotic patients with serum sodium 115 – 140 mEq/LPacientes cirróticos euvolémicos o hipervolémicos estables con un valor de sodio sérico comprendido entre 115 y 140 mEq/LMedDRA version: 9.1Level: PTClassification code 10019641Term: Hepatic cirrhosisMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaEUCTR2007-001661-15-ESAstellas Pharma US, Inc20