ACTRN12621000315819招募中3 期
Evaluating the effect of erdosteine on respiratory exacerbation rate of children and adults with bronchiectasis - a double-blind, randomised controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 2 Years 至 49 Years（—）
- 性别
- All
入选标准
- •1. Participants aged 2 to 49 years
- •2. Bronchiectasis with at least 2 acute respiratory exacerbations in the last 18 months AND
- •3. Able to be contacted for the 15 month follow up period.
排除标准
- •1.Cystic fibrosis
- •2.Contraindication to erdosteine use (e.g. liver dysfunction, hypersensitivity, renal failure, deficiency of the cystathionine-synthetase enzyme, phenylketonuria, active peptic ulcer)
- •3.Pregnant, pregnancy planned (in next 12 months) or nursing mothers
- •4.Previously randomised
- •5.Hospitalised in the last 4 weeks for respiratory instability
- •6.Participation in another intervention concurrent RCT.
研究者
相似试验
进行中（未招募）
不适用
Evaluation of erdosteine effect on systemic inflamation biomarkers during COPD exacerbations - ERD/inflammation/COPDCOPD exacerbationMedDRA version: 9.1Level: SOCClassification code 10038738EUCTR2008-008529-32-IT.O.PNEUMOLOGIA- AZ. USL1 DI MASSA E CARRARA
进行中（未招募）
1 期
The efficacy and safety of erdosteine in the long term therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, randomised, double blind, placebo-controlled, parallel group, multicenter, study - Study RESTOREChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPDEUCTR2008-008192-34-SKEDMOND PHARMA S.r.l.542
进行中（未招募）
不适用
The efficacy and safety of erdosteine in the long term therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, randomised, double blind, placebo-controlled, parallel group, multicenter, study - Study RESTOREChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2008-008192-34-DKEDMOND PHARMA S.r.l.542
进行中（未招募）
不适用
The evaluation of efficacy and safety of erdosteine, a mucolytic anti-oxidant drug, in Chronic Bronchitis with Airway Obstruction.Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2008-008192-34-BEEDMOND PHARMA S.r.l.542
进行中（未招募）
1 期
The efficacy and safety of erdosteine in the long-term therapy of chronic obstructive pulmonary disease (COPD). A 12-month, randomised, double-blind, placebo-controlled, parallel group, multicenter study. - Study RESTOREChronic Obstructive Pulmonary DiseaseMedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPDEUCTR2008-008192-34-GBEdmond Pharma467