A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mucociliary clearance (MCC) rate
研究概览
简要总结
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
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)
盲法说明
Dupilumab and placebo will be provided in identically matched 1.14 mL pre-filled syringes. To protect the blind, each treatment kit of 1.14 mL (dupilumab / placebo) glass pre-filled syringes will be prepared such that the treatments (dupilumab and its matching placebo) are identical and indistinguishable and will be labeled with a treatment kit number. The randomized treatment kit number list will be generated by Sanofi Regeneron
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
- •Age > 18
- •Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
- •Reversibility >/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
- •FEV1/Forced Vital Capacity (FVC)<75%
- •Blood Eosinophils (EOS) >300 cells per mm3
- •Exhaled Nitric Oxide (FeNO) >25 parts per billion (ppb)
- •Asthma Control Test (ACT) score <20
排除标准
- •Pregnant, nursing, or unwilling to test for pregnancy
- •Current smoker or >10 pack year smoking history
- •Body Mass Index (BMI)>37
- •Respiratory infection in the last 30 days
- •Use of antibiotics or oral prednisone in the last 30 days
- •Current or previous use of dupilumab
- •Current or recent use of anti-IL-5 therapies
- •Any other criteria that place the subject at unnecessary risk
- •Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
- •History of non-skin cell cancer in the last 5 years
- •Drug or alcohol addiction in the last 5 years
- •Any other uncontrolled disease
研究组 & 干预措施
Placebo
Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.
干预措施: Placebo (Other)
Dupilumab
Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Change in mucociliary clearance (MCC) rate
时间窗: Measured at 12 weeks after the start of treatment
MCC is measured using an aerosol-based nuclear imaging technique
次要结局
- Change in FEV1% predicted(Measured from baseline to 12 weeks after start of treatment)
- Change in ACT score(Measured from baseline to 12 weeks after start of treatment)
- Change in sputum eosinophils and T2 gene mean(Measured from baseline to 12 weeks after start of treatment)
- Change in mucus plugging score by CT(Measured from baseline to 12 weeks after start of treatment)
- Whole lung MCC90, AAC90(Measured from baseline to 12 weeks after start of treatment)
- Peripheral and central lung MCC90, MCC240, AAC90(Measured from baseline to 12 weeks after start of treatment)
研究者
Sally E. Wenzel MD
Professor
University of Pittsburgh