EUCTR2019-000261-21-FR进行中（未招募）1 期
A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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. Male or female patients / 12 years of age or older at screening;
- •2. Documented diagnosis of cystic fibrosis including:
- •positive sweat chloride = 60 mEq/L, by pilocarpine iontophoresis or
- •a genotype with 2 identifiable mutations consistent with cystic fibrosis accompanied by one or more clinical features with cystic fibrosis phenotype;
- •3. FEV1 = 40% and = 90% of predicted values at screening and at predose at Visit 2 (randomisation).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 77
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of acute upper or lower respiratory tract infection within 4 weeks prior to randomisation based on investigator’s judgement;
- •2. Pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics or oral corticosteroids within 4 weeks prior to randomisation;
- •3. Women of childbearing potential
研究者
相似试验
招募中
2 期
The effects of cannabidiol (CBD) on psychosocial stress, situational anxiety and nausea experienced in a virtual reality environmentPsychosocial stressSituational anxietyCybersicknessMental Health - AnxietyMental Health - Other mental health disordersMotion sicknessACTRN12623000872639niversity of Sydney74
进行中（未招募）
1 期
Tralokinumab monotherapy for adolescent subjects with moderate-to-severe atopic dermatitis - ECZTRA 6Atopic DermatitisMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2017-005143-33-PLEO Pharma A/S301
进行中（未招募）
1 期
A study of mepolizumab (study medicine) as an add-on therapy in subjects with severe uncontrolled asthmaSubjects with severe asthmaMedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-002513-27-ESGlaxoSmithKline, S.A.544
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, parallel-group, multicenterstudy to demonstrate improvement of symptoms of RLS in subjects withmoderate to severe idiopathic RLS with daytime symptoms who takeoxycodone/naloxone prolonged release (OXN PR) compared to subjects takingplacebo (PLA).Estudio multicéntrico, aleatorizado, con doble anonimato, controlado conplacebo, en grupos paralelos, para demostrar la mejoría de los síntomas delsíndrome de las piernas inquietas (RLS) en pacientes con RLS idiopático, demoderado a grave, con síntomas diurnos, que toman oxicodona/naloxona deliberación prolongada (OXN PR), comparados con el grupo tratado con placebo(PLA).Sindrome de Piernas inquietasRestless Legs SyndromeMedDRA version: 12.0Level: LLTClassification code 10058920Term: Restless legs syndromeEUCTR2009-011107-23-ESMundipharma Research GmbH & Co. KG300
进行中（未招募）
1 期
A study of mepolizumab (study medicine) as an add-on therapy in subjects with severe uncontrolled asthma.Subjects with severe asthmaMedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-002513-27-EEGlaxoSmithKline Research & Development Ltd544