NCT01134835终止4 期
PPAR-gamma: a Novel Therapeutic Target in Asthma?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- FEV1 after 12 weeks treatment
研究概览
简要总结
To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 of either sex with a clinical diagnosis of asthma,
- •FEV1 ≥ 60% predicted and an increase in FEV1 of greater than 12% following inhaled salbutamol 400μg or Peak Expiratory Flow (PEF) variability >12% during run-in.
- •Allowed medication: 0-800μg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist.
排除标准
- •Current smoking,
- •> 10 pack years smoking history,
- •Treatment with leukotriene antagonists,
- •Liver or cardiovascular disease,
- •Oral steroid treatment or exacerbation within 6 weeks,
- •Females who are pregnant, lactating or not using adequate contraception,
- •Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis),
- •Oral or insulin treatment for diabetes,
- •Treatment with gemfibrozil or rifampicin.
研究组 & 干预措施
IMP Pioglitazone
Experimental
Pioglitazone 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.
干预措施: IMP Pioglitozone (Drug)
Placebo
Placebo Comparator
Placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.
干预措施: placebo (Other)
结局指标
主要结局
FEV1 after 12 weeks treatment
时间窗: week 12
次要结局
- Change in symptoms(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
PPAR-gamma: A noval therapeutic target for asthmaMedDRA version: 9.1 Level: LLT Classification code 10003553 Term: AsthmaAsthmaEUCTR2008-004112-13-GBottingham University100
进行中（未招募）
不适用
Clinical role of PPAR gamma activator (pioglitazone) in reducing the gastric phlogosis in patiens with istological gastritis.Treatment of patients with gastric phlogosis (infected by Helicobacter pylori)MedDRA version: 9.1Level: LLTClassification code 10017904Term: Gastroenteritis helicobacterEUCTR2005-001218-42-ITAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
已完成
早期 1 期
In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe AsthmaAsthmaNCT02740049Imperial College London9
撤回
不适用
MRI and Lung Function Measures of Benralizumab Response in AsthmaAsthmaNCT04182802Sheffield Teaching Hospitals NHS Foundation Trust
已完成
2 期
Fenofibrate in Ulcerative ColitisInflammatory Bowel DiseasesNCT05753267Tanta University60