A randomised, double-blind, placebo-controlled trial to evaluate the effect of Epstein-Barr virus suppression in chronic obstructive pulmonary disease (EViSCO trial). - Epstein-Barr virus suppression in COPD (EViSCO)

Belfast Health and Social Care Trust (BHSCT)0 个研究点目标入组 88 人开始时间: 2019年6月20日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•1. Age over 18 years.
•2. 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.
•3. Presence of Epstein-Barr virus on sputum PCR analysis.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 58
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Respiratory failure (defined as long-term oxygen therapy).
•2. 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).
•3. A diagnosis of asthma.
•4. Patients with known hypersensitivity to valaciclovir or aciclovir.
•5. Patients unable to swallow study drug capsules.
•6. Established diffuse interstitial lung disease (e.g. Idiopathic Pulmonary Fibrosis).
•7. Established diagnosis of symptomatic bronchiectasis.
•8. Patients known to be pregnant or breastfeeding.
•9. Patients with an estimated creatinine clearance less than 50ml/minute.
•10. Known participation in investigational medicinal product trials within 30 days.
•11. Patients who do not adequately understand verbal or written information.
•12. Concomitant use of nephrotoxic medicinal products or medicines associated with altered renal tubular secretion. Theseinlcude aminoglycosides, organoplatinum compounds, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus,tenofovir, cimetidine and probenecid. As iodinated contrast used in radiological examinations can be nephrotoxicany patients with planned radiological contrast studies will be deferred for a reasonable time until after their contrast.
•13. For the exploratory bronchoscopy sub-tudy 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).

发起方

Belfast Health and Social Care Trust (BHSCT)