A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 491
- 主要终点
- Post-bronchodilator FEVI
研究概览
简要总结
This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 44 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of >44 years of age, with >10 pack-year smoking history;
- •women not of child-bearing potential;
- •ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema;
- •willing to be switched to optimal COPD therapy.
排除标准
- •off oral steroids >28 days prior to enrollment;
- •>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening;
- •exposure to synthetic oral retinoids in past 12 months;
- •history of allergy or sensitivity to retinoids.
研究组 & 干预措施
Placebo
po daily
干预措施: Placebo (Drug)
RAR Gamma
5mg po daily
干预措施: RAR Gamma (Drug)
结局指标
主要结局
Post-bronchodilator FEVI
时间窗: At intervals throughout study, and 2 and 6 months after cessation of study drug
次要结局
- DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.(At intervals throughout study)
- AEs, SAEs, retinoid side effects, lab parameters.(Thoughout study)