A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Reactions (SARs)
研究概览
简要总结
COPD is a major public health problem and will shortly become the third most common cause of global mortality. There are currently no treatments that can meaningfully alter the progression of COPD or the time to death. Consequently novel therapeutic strategies for COPD are urgently required. This will be a randomised, double-blind, placebo-controlled, trial of Epstein-Barr virus suppression in COPD. Participants will be randomised to receive valaciclovir 1 gram three times daily for 8 weeks or matching placebo. The study will measure EBV suppression using quantitative PCR. Secondary outcomes will include Lung function quality of life and drug tolerability. The exploratory analysis will evaluate biomarkers of airway inflammation within the sputum and blood.
详细描述
The study will evaluate the role of antiviral therapy in COPD. Previous research has demonstrated that Epstein-Barr virus (EBV) is more frequently identified in the airways of COPD sufferers when compared to unaffected smokers. It is not known whether suppression of EBV helps in COPD.
Hypothesis. The primary hypothesis is that treatment with valaciclovir is safe and will suppress Epstein-Barr virus in the sputum of patients with COPD.
Trial objectives. To conduct a randomised, double-blind, placebo-controlled, trial of Epstein-Barr virus suppression in COPD.
To evaluate the safety of valaciclovir (1 gram three times daily for 8 weeks) for the suppression of Epstein-Barr virus in COPD.
To study the biological effects of EBV suppression on airway and blood markers of inflammation in COPD.
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
This will be randomised, double-blind trial with matching placebo.
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
- •Age over 18 years.
- •Clinical diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease criteria (FEV1/FVC <70%) with GOLD 2 and GOLD 3 airflow obstruction (FEV1 30-80% predicted) with significant symptoms.
- •Presence of Epstein-Barr virus on sputum PCR analysis.
排除标准
- •Respiratory failure (defined as long-term oxygen therapy).
- •An acute exacerbation of COPD in the previous month (defined as an acute, sustained worsening of symptoms that is beyond normal day-to-day variations).
- •A diagnosis of asthma.
- •Patients with known hypersensitivity to valaciclovir or aciclovir.
- •Patients unable to swallow study drug capsules.
- •Established diffuse interstitial lung disease (e.g. Idiopathic Pulmonary Fibrosis).
- •Established diagnosis of symptomatic bronchiectasis.
- •Patients known to be pregnant or breastfeeding.
- •Patients with an estimated creatinine clearance less than 50ml/minute.
- •Known participation in investigational medicinal product trials within 30 days.
- •Patients who do not adequately understand verbal or written information.
- •Concomitant use of nephrotoxic medicinal products or medicines associated with altered renal tubular secretion. These include aminoglycosides, organoplatinum compounds, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus,tenofovir, cimetidine and probenecid. As iodinated contrast used in radiological examinations can be nephrotoxicity patients with planned radiological contrast studies will be deferred for a reasonable time until after their contrast.
- •For the exploratory bronchoscopy sub-study patients will require adequate oxygen saturations, FEV1 >0.5 L and will not be performed while patients are taking aspirin or clopidogrel (BTS guidelines 2013).
研究组 & 干预措施
Active arm
Valaciclovir 1 gram orally three times daily for 8 weeks.
干预措施: Valaciclovir (Drug)
Placebo arm
Matching placebo capsules (containing Avicel blend). Two capsules three times daily for 8 weeks.
干预措施: Placebo capsules (containing Avicel blend) (Drug)
结局指标
主要结局
Incidence of Serious Adverse Reactions (SARs)
时间窗: Up to 28 days after completion of the study drug
The primary outcome measure will be drug safety of valaciclovir (1 gram three times daily for 8 weeks) as defined by the incidence of Serious Adverse Reactions (SARs).
EBV viral load
时间窗: Change from baseline to 8 weeks.
The primary efficacy outcome is suppression of Epstein-Barr virus in the sputum measured using quantitative PCR at baseline and 8 weeks.
次要结局
- Drug tolerability as measured by the proportion of tablets self-administered.(8 weeks)
- Forced expiratory volume in 1 second (FEV1)(Change from baseline to 8 weeks)