EUCTR2007-004158-10-DE进行中（未招募）不适用
A single site, exploratory, phase I / II, randomised trial comparing the effect of Helium/Oxygen mixtures (He/O2 78:22 and He/O2 65:35) to medical air on pulmonary function in moderate / severe asthma and COPD patients and healthy volunteers
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AIR LIQUIDE
- 入组人数
- 30
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
- •The criteria for inclusion are:
- •All subjects/patients:
- •?Male or female aged = 18 and ? 80 years old,
- •?Willing and able to complete the requirements of this study including the signature of the written informed consent,
- •?Able to complete the study in 5 working days or less,
- •?Able to perform pulmonary function tests
- •Healthy volunteers:
- •?Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
- •?Having pulmonary function tests within the normal range (according to predicted values for age, sex and height as referenced in ATS/ERS Task force : standardisation of lung function testing” c.f. Euro respiratory journal 2005;26:948-968)
- •Patients with moderate / severe persistent asthma:
- •?Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines, see Appendix 12.E),
- •?Never smoker or patient who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
- •?Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency, acute care setting and no admission to hospital for acute asthma,
- •?Reversibility with 400 µg salbutamol = 12% increase FEV1 (+ 200 mL) compared to baseline. Should the investigator be able to provide historical information of patient’s response to salbutamol within the last 1 year before selection, then the bronchial reversibility test is not to be carried out,
- •Patients with moderate / severe COPD:
- •?Aged = 45 and ? 80 years old,
- •?Documented clinical diagnosis of moderate or severe COPD (according to GOLD 2006 guidelines, see Appendix 12.F),
- •?With a smoking history of 10 pack-years or more,
- •?Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD medication, no treatment for COPD in an emergency, acute care setting and no admission to hospital for COPD exacerbation.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The criteria for exclusion are:
- •?Obese subject/patient having a Body Mass Index (BMI) > 30,
- •?Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients,
- •?Daily need for 12 hours or more of long term oxygenotherapy,
- •?Pregnant or lactating woman, Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner. For patients using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
- •?Any contra-indication to perform pulmonary function tests or light exercise,
- •?Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
- •?Known sensitivity to the investigational products,
- •?Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study,
- •?Legal status which prohibits informed consent,
- •?Participation in any interventional clinical trial within 30 days prior to selection (Visit 0) or current participation in another investigational product trial.
研究者
相似试验
已完成
不适用
An exploratory Phase I randomized, single-site, double-blind, active-controlled, parallel-group, single-administration, dose-escalation trial to investigate the safety and tolerability of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine), in perineural administrations for brachial plexus blockade in healthy subjects.plexus-brachialisblokkadeBrachial plexus blockadeNL-OMON46410Grünenthal GmbH111
进行中（未招募）
不适用
A phase II, open, single centre, exploratory study to evaluate the safety and immunogenicity of one booster dose of a GSK Biologicals’ Hepatitis B vaccine Engerix™-B or a of GSK Biologicals’ HIV candidate vaccine (732461), administered intramuscularly, in conjunction with the administration of a single oral dose of chloroquine in healthy adults. - EARLY-CLINRES-004Immunisation against Hepatitis B and HIV in healthy adults aged between 18-52 years old, inclusive.EUCTR2009-012223-29-BEGlaxoSmithKline Biologicals
进行中（未招募）
1 期
A clinical trial investigating Iloprost as medication to improve bone healing in patients with upper arm bone fracture.Proximal humeral fractureEUCTR2017-003813-24-DECharité-Universitätsmedizin Berlin30
招募中
1 期
A phase I/II, non randomized, monocentric open-label study of autologous CD34+ cells transduced with the G1XCGD lentiviral vector in patients with X-Linked Chronic Granulomatous DiseaseTreatment of X-linked Chronic Granulomatous DiseaseMedDRA version: 20.0Level: PTClassification code: 10008906Term: Chronic granulomatous disease Class: 100000004850CTIS2024-512790-27-00Genethon5
已完成
2 期
An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.schnitzler syndrome10003816NL-OMON40255Servier R&D Benelux5