Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive lung disease (COPD) patients with frequent exacerbations.
This is a Phase II, pilot randomized double blind control study, meaning this study will help assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the vein). Immunoglobulins are part of the immune system and help the body fight infections. Participants will be assigned to either receiving the Ig treatment or normal saline as a control product every 4 weeks for 12 months.
Participants will continue on current standard therapy as determined by their treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adult patient with AECOPD (clinically dominant AECOPD in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism)
- •Diagnosis of severe COPD (post bronchodilator FEV1 <50%, FEV1/FVC ratio <0.7) made by standard spirometry within previous 12 months or within three days of admission if previous PFT data is not available
- •Age >40 years
- •>10 pack year smoking history
- •At least one COPD exacerbation in the previous 12 months before enrollment, defined by having had documented inpatient or outpatient treatment by physician with antibiotics and/or prednisone for physician diagnosed COPD exacerbation
- •Expected to live > 12 months
排除标准
- •Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis)
- •Underlying malignancy (including chronic lymphocytic leukemia)
- •History of hematopoietic stem cell transplant or solid organ transplant
- •Current treatment with a biological therapy for other conditions
- •Concomitant significant immunodeficiency or on immunosuppressive treatment other than for COPD
- •Alpha-1 antitrypsin deficiency
- •Significant proteinuria (dipstick proteinuria ≥ 3+ or known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis)
- •IgA deficiency (IgA <0.1 g/L)
- •Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html)
- •Obesity (BMI ≥35 kg/m²)
- •Pregnancy
研究组 & 干预措施
Intervention Arm 1: Treatment
Baseline Ig < 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Baseline Ig > or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
干预措施: Intravenous immunoglobulin (IVIG) (Drug)
Intervention Arm 2: Control
Baseline Ig < 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Baseline Ig > or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
干预措施: Normal Saline (Drug)
结局指标
主要结局
Recruitment
时间窗: 52 weeks
Average number of patients being recruited per month. The study meets primary outcome if at least 4 patients can be recruited per month on average.
Adherence and protocol compliance
时间窗: 104 weeks
Number and percentage of recruited patients adhere to the allocated treatment and protocol. We aim to achieve 80% adherence rate which is defined as at least 80% of patients adhere to 80% of allocated treatment and protocol
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE(104 weeks)
- Tolerability of treatment(104 weeks)
- Efficacy trend: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) rates(104 weeks)
- Efficacy trend: Health status(104 weeks)
- Efficacy trend: % predicted FEV1(104 weeks)
- Efficacy trend: FEV1/FVC(104 weeks)
- Efficacy trend: Health services use(104 weeks)
- Efficacy trend: Quality of life(104 weeks)
- Efficacy trend: Health care system cost(104 weeks)