Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.

FLUIDDA nv1 个研究点分布在 1 个国家目标入组 13 人开始时间: 2015年9月最近更新: 2018年3月21日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方
入组人数: 13
试验地点: 1
主要终点: Changes in Air trapping

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image 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
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
•Written informed consent obtained
•Patient with Body mass index (BMI) ≥ 20
•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
•COPD patient with GOLD stages C and D
•Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
•Patient with smoking history of at least 10 pack-years
•Patient takes a combination therapy of LABA/ LAMA 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 as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
•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 inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
•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

Active Comparator

Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment

干预措施: HRCT scan (Radiation)

Roflumilast

Active Comparator

Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment

干预措施: Roflumilast (Drug)

Placebo

Placebo Comparator

Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

干预措施: HRCT scan (Radiation)

Placebo

Placebo Comparator

Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

干预措施: Placebo of Roflumilast (Drug)