The Potential Anti-inflammatory Effect of Roflumilast as Add-on Therapy in The Management of Hospitalized Patients With Mild Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in clinical picture (two-point reduction in patient's admission status)
研究概览
简要总结
- Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.
- Approximately 76 hospitalized patients with ARDS will be enrolled in this study.
- Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.
详细描述
• Methodology in details:
- Informed consent will be obtained from included participants.
- Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.
- Approximately 76 hospitalized patients with ARDS will be enrolled in this study.
- Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.
- Randomization:
Randomization will be in 1:1 ratio using permuted blocks of different sizes. Random.org website will be used for random selection of a sequence of blocks. The latter will be used to generate a randomized list which will be generated and stored by a third party independent of the study team. For allocation concealment, the list will be used to make sequentially numbered sealed opaque envelopes, each containing the sequential randomization number and allocation of subsequent cases. Envelopes will be handed to the study team member responsible for medication preparation. Each envelope will be opened only after:
- Screening for eligibility
- Obtaining consent
- Recording baseline characters The treatment allocation dictated in the envelope will be documented in the case record form and will be subject to audit to assure correct randomization according to the original list.
- Intervention:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to sign informed consent
- •Patients >18 years old male or female
- •Mild cases of ARDS according to the Berlin criteria (PaO/FiO 200 to 300 mmHg)
排除标准
- •Pregnancy and breast feeding
- •History of hypersensitivity to roflumilast
- •Patients with mechanical respiratory assistance (severe ARDS)
- •Patients under treatment with roflumilast for COPD
- •Patients with psychiatric diseases
- •Hepatic cirrhosis (Child-Pugh score B or C)
- •Refused to sign informed consent
研究组 & 干预措施
Roflumilast add-on
Eligible patients will take 500 Mcg of roflumilast once daily (up to 28 days) plus standard of care.
干预措施: Roflumilast (Drug)
Placebo control
Eligible patients will take placebo plus standard of care.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in clinical picture (two-point reduction in patient's admission status)
时间窗: Follow up for up to 28 days.
Defined as a two-point reduction in patient's admission status on a five-point ordinal scale, or live discharge from hospital whichever came first. • The five-point ordinal scale is as follow: 1. Discharge 2. Hospital admission, not requiring oxygen supplement 3. Hospital admission, requiring oxygen supplement 4. Hospital admission for high flow oxygen therapy or non-invasive mechanical ventilation 5. Hospital admission for mechanical ventilation or extracorporeal membrane oxygenation
次要结局
- Evaluation of change in systemic inflammatory parameters, including ferritin.(Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.)
- Evaluation of change in systemic inflammatory parameters, including CRP.(Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.)
- Evaluation of change in systemic inflammatory parameters, including LDH.(Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.)
- Total hospital stay.(Follow up for up to 28 days.)
研究者
Eman Abdel Moniem Abdel Rasheed
Professor Emeritus
Cairo University