ISRCTN18210817已完成3 期
Evaluation of triple therapy using magnetic resonance imaging in asthma (ETHA)
Western University (Canada)0 个研究点目标入组 31 人开始时间: 2024年3月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature
- •2. Provision of written, informed consent prior to any study-specific procedures
- •3. Males and females with a clinical diagnosis of eosinophilic asthma (based on FENO =40ppb, blood eosinophilia =200 cells/µl at screening) aged 18 to 70 years, inclusively, at the time of Visit 1 (enrolment), under the care of a respirologist
- •4. FEV1 =35 and =80% predicted
- •5. Participant is a current non-smoker and non-vaper, having not smoked tobacco or cannabis, pipe or cigar or vaped any product for at least 12 months prior to the study with a tobacco smoking history of no more than 1 pack-year (i.e. 1 pack per day for 1 year).
- •6. Women of childbearing potential (after menarche) must use a highly effective form of birth control (confirmed by the investigator or designee)
- •A highly effective form of birth control includes true sexual abstinence, a vasectomized sexual partner, Implanon®, female sterilization by tubal occlusion, any effective intrauterine device (IUD)/levonorgestrel intrauterine system (IUS), Depo-ProveraTM injections, oral contraceptive and Erva PatchTM or NuvaringTM
- •7. Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrolment, throughout the study duration, and 8 weeks after the last dose of the study drug, with negative pregnancy test result at Visit 1
- •8. Male participants who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of the study drug until 8 weeks after the last dose
- •9. Participant has documented treatment with a stable dose of low to medium dose inhaled corticosteroids (defined as >250 and =500 mcg fluticasone proprionate/day or equivalent or, >400 to =800 mcg Budesonide/day for at least 6 months prior to enrolment
- •long-acting ß2-agonist (LABA) for at least 6 months prior to enrolment
- •10. Participant has blood eosinophils = 200 cells/µl or FENO =25ppb at Visit 1 for all participants except for those with previous biologic therapy without washout who will be required to washout prior to screening.
- •11. Participant has ACQ-6 = 1.5 at visit 1
- •12. Participant has a history of poorly controlled asthma (i.e. =2 exacerbations in the past 24 months)
排除标准
- •1. Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material
- •2. Participant has clinically important pulmonary disease other than asthma (e.g. active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency and primary ciliary dyskinesia) or been diagnosed with pulmonary or systemic disease other than asthma that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), except for those atopic conditions that can be associated with asthma (e.g. allergic rhinitis, sinusitis with or without polyposis, eczema, and eosinophilic esophagitis)
- •3. 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 Qualified Investigator and/or could affect the safety of the participant throughout the study, influence the findings of the study or their interpretations, or impede the participant's ability to complete the entire duration of the study, as assessed by the Qualified Investigator.
- •4. Known history of allergy or reaction to the study drug formulation
- •5. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date of informed consent
- •6. Clinically significant asthma exacerbation, defined as a change from baseline deemed clinically relevant in the opinion of the Qualified investigator, including those requiring the use of OCS, or an increase in maintenance dosage of OCS within 30 days prior to the date of informed consent. Participants with an exacerbation after providing informed consent but prior to treatment start will be excluded from the study
- •7. Receipt of immunoglobulin or blood products within 30 days prior to the date of informed consent
- •8. Receipt of live attenuated vaccines 30 days prior to the date of enrolment
- •9. Previously randomized in any FF/UMEC/VI 200/62.5/25ug study
- •10. Planned surgical procedure during the conduct of the study
- •11. Concurrent enrolment in another clinical trial
- •12. Participant has history of alcohol or drug abuse within 12 months prior to the date of informed consent
- •13. Participant is a female who is =8 weeks post-partum or breast feeding an infant
- •14. Participant is pregnant, or intends to become pregnant during the time course of the study
- •15. Participant is unable to perform MRI breath-hold maneuver
- •16. Participant is unable to perform spirometry maneuver
- •17. Participant is hospitalized or has had a major surgical procedure, major trauma requiring medical attention, or significant illness requiring medical attention within 4 weeks of Visit 1
- •18. Participant has a blood pressure of >150 mmHg systolic or >95 mmHg diastolic on more than 2 measurements done >5 minutes apart at Visit 1
- •19. In the opinion of the investigator, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- •20. Participant has implanted mechanically, electrically or magnetically activated device or any metal in their body,
研究者
相似试验
进行中（未招募）
3 期
Evaluation of Triple Therapy Using Magnetic Resonance Imaging in AsthmaAsthmaNCT04651777Dr. Grace Parraga31
已完成
3 期
Magnet therapy ,acupuncture and isometric exercise in treatment knee osteoarthritisIRCT20181017041371N1Bagheiat-allah University of Medical Sciences60
招募中
不适用
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSDPost Traumatic Stress DisorderNCT03932773The University of Texas at Dallas330
招募中
3 期
A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)locally advanced unresectable squamous cell carcinoma of the thoracic esophagusJPRN-UMIN000031165Japan Clinical Oncology Group (JCOG)230
已完成
不适用
Evaluation of clinical efficacy of Magnetic Resonance Spectroscopy for gynecological pelvic abscessJPRN-UMIN000016705Keio University School of Medicine, Department of Obstetrics & Gynecology17