Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Changes in airway geometry and function using CT based functional respiratory imaging.
研究概览
简要总结
In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.
Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient ≥ 30 years old
- •Patient with BMI ≥ 20
- •Written informed consent obtained
- •Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
- •Patient should be treated according to GOLD guidelines
- •COPD patient with GOLD stages III until IV
- •Patient with smoking history of at least 10 pack-years
- •Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1
- •Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
排除标准
- •Pregnant or lactating females
- •Patient with severe immunological diseases and/ or severe acute infectious diseases.
- •Patient with heart failure
- •Patient with diagnosis of cancer (except basal cell carcinoma)
- •Patient with a history of depression associated with suicidal ideation or behaviour
- •Patient with moderate or severe hepatic impairment.
- •Patient with lactose intolerance
- •Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- •Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).
研究组 & 干预措施
Roflumilast
干预措施: Roflumilast (Drug)
Roflumilast
干预措施: Functional Respiratory Imaging (Radiation)
Placebo
干预措施: Placebo of Roflumilast (Drug)
Placebo
干预措施: Functional Respiratory Imaging (Radiation)
结局指标
主要结局
Changes in airway geometry and function using CT based functional respiratory imaging.
时间窗: At baseline and after 6 months of treatment
The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®.
次要结局
- Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)(At baseline and after 6 months of treatment)
- Health related quality of life(At baseline and after 6 months of treatment)