EUCTR2005-003870-88-DE进行中（未招募）不适用
Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4
Mukoviszidose Institut gGmbH i. G.0 个研究点目标入组 160 人开始时间: 2006年8月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Male or female patients older than 8 years (pediatric 8 – 17 years inclusive; adult older than 18 years)
- •Confirmed diagnosis of CF (positive sweat chloride above 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype
- •Able to perform acceptable spirometric maneuvers, according to ATS standards
- •FEV1 > 40% predicted and < 90% predicted
- •Are the trial subjects under 18? yes
- •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
- •Patients with a significant history of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial as judged by the Investigator. Relevance” in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of inhaled glutathione in allergic patients per se
- •Concomitant inhaled thiol-containing medications (e.g., inhaled N-acetylcysteine).
- •Such medication had to be finished at least 2 weeks before the screening visit.
- •Oral N-acetylcysteine may be continued.
- •New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
- •Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit
- •Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion is to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives
- •Female patients of child bearing potential who are sexually active and not using a medically approved form of contraception
- •Patients with documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year). The intention of this exclusion criterion is to be consistent with the current policy within the CF community for reducing the risk of B. cepacia cross infection
- •Patients who have started a new chronic medication for CF within 4 weeks of screening.
- •Patients who are on a cycling medication regimen must have completed at least 3 cycles prior to the screening visit and the medication cycles should be in phase with the follow-up appointments
- •Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This includes significant hematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes may participate if their disease is under good control prior to screening. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other egibility criteria are satisfied
研究者
相似试验
招募中
4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent orofacial herpes infections.2024-514358-56-00Labo'Life Belgium140
进行中（未招募）
1 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LVERU®JUNIOR and 2LVERU® on the treatment of warts. EVAsION Studyon genital warts infectionMedDRA version: 21.1Level: LLTClassification code: 10010115Term: Common warts Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10035158Term: Plantar warts Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10047828Term: Warts Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10035150Term: Planar warts Class: 10029104CTIS2024-514476-40-00abo'Life Belgium162
进行中（未招募）
1 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infectioEpstein-Barr Virus infectionMedDRA version: 21.0Level: LLTClassification code: 10056907Term: EBV antigen positive Class: 10022891MedDRA version: 21.1Level: LLTClassification code: 10056906Term: EBV antibody positive Class: 10022891MedDRA version: 23.1Level: LLTClassification code: 10014078Term: EBV infection reactivation Class: 10021881MedDRA version: 20.0Level: LLTClassification code: 10014077Term: EBV infection Class: 10021881CTIS2024-514222-24-00abo'Life Belgium88
进行中（未招募）
1 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LPAPI® on the clearance of high-risk oncogenic HPV genital infections (PAPION study)MedDRA version: 25.0Level: LLTClassification code: 10086966Term: HPV screening Class: 100000004848MedDRA version: 25.0Level: LLTClassification code: 10086964Term: HPV infection Class: 100000004848MedDRA version: 20.0Level: SOCClassification code: 10038604Term: Reproductive system and breast disorders Class: 20MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1Human Papillomavirus infectionCTIS2024-513969-39-00abo'Life Belgium284
进行中（未招募）
1 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent orofacial herpes infections.CTIS2024-514358-56-00abo'Life Belgium140