NCT04203797已完成4 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 24
- 主要终点
- Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
研究概览
简要总结
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.
The secondary objectives of the study are:
- To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma
- To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A physician diagnosis of asthma
- •Pre-bronchodilator FEV1 between 30% and 75% predicted at both the screening and baseline visits
- •Bronchodilator reversibility defined as >200 mL and 12% increase in FEV1 post-administration of a short-acting beta agonist (SABA). A patient may also qualify if there is a documented history of bronchodilator reversibility or positive methacholine challenge test within 12 months prior to the screening visit
- •Stable background therapy for at least 3 months with a stable dose ≥4 weeks prior to the baseline visit of a medium-to-high dose ICS (fluticasone propionate ≥250 to 1000 μg twice daily [BID] or equivalent) in combination with at least a second controller medication (eg, long-acting beta agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA], theophylline, etc.); a third controller is allowed and with the same stabilization requirements
- •Blood eosinophil count ≥300 cells/μL for patients not on maintenance OCS at the screening visit
- •ACQ-5 score ≥1.5 at the screening and baseline visits
排除标准
- •Body mass index >35 kg/m2 at screening
- •Current smoking, vaping or tobacco chewing or cessation of any of these within 6 months prior to randomization, or >10 pack years smoking history
- •Patients who require supplemental oxygen at screening
- •Clinically significant cardiac disease as described in the protocol
- •Uncontrolled hypertension at screening or baseline
- •Participation in exercise or physical rehabilitation program within last 6 months prior to screening or planned during the study
- •Previous use of dupilumab
- •Anti-IgE therapy (eg, omalizumab [Xolair®]) within 130 days prior to visit 1 or any other biologic therapy (including anti-IL5, anti-IL-5R, anti-IL4Rα, anti-IL-13 mAb) or systemic immunosuppressant (eg, methotrexate, any anti-tumor necrosis factor mAbs, Janus kinase inhibitors, B- and/or T-cell targeted immunosuppressive therapies) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 3 months or 5 half-lives prior to screening, whichever is longer
- •Exposure to another investigative drug (monoclonal antibodies as well as small molecules) within a period prior to screening, of <3 months or <5 half-lives (whichever is longer)
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- •Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
dupilumab
Experimental
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
干预措施: dupilumab (Drug)
Matching placebo
Experimental
Matching dupilumab
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
时间窗: Up to week 12
CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
次要结局
- Change From Baseline to Week 12 in Average Number of Steps Walked Per Day(Up to week 12)
- Change From Baseline to Week 12 in Total Energy Expenditure(Up to week 12)
- Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity(Up to week 12)
- Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)(Up to week 12)
研究者
研究点 (24)
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