Valaciclovir for Epstein-Barr Virus Suppression in Moderate-to-Severe COPD: A Randomized Double-Blind Placebo-Controlled Trial.

"Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: D. A. L. has received speaker fees from GlaxoSmithKline. H. G.-P. has received grants from Pfizer. M. C. M reports funding from Medical Research Council (MRC). G. G. E. and A. J. L. report funding from IMI. D. S. has received fees for consultancy from Aerogen, AstraZeneca, Boehringer, Chiesi, Cipla, CSL Behring, Epiendo, Genetech, GlaxoSmithKline, Glenmark, Gossamerbio, Kinaset, Menarini, Novartis, Pulmatrix, Sanofi, Synairgen, Teva, and Theravance. D. F. M. reports funding from GlaxoSmithKline and personal fees for consultancy from GlaxoSmithKline, SOBI, Peptinnovate, Boehringer Ingelheim, and Bayer. C. C. T. reports grants from MRC, NIHR, NICHS and Chiesi. J. C. K. reports grants from Pfizer UK. None declared (D. J. F., V. B., G. L., M. M., C. C., D. L.)."

"Funding/Support This study was funded by the Mater Hospital YP Trustee Fund (registered with The Charity Commission for Northern Ireland [Identifier: NIC100084]). D. A. L. has received salary and research costs from Mater Hospital YP Trustees. M. C. M. reports funding from Medical Research Council (MRC) for current post [Grant MR/T016760/1] and previous doctoral study [Grant MR/P022847/1]. D. F. M. reports institutional grants from the UK National Institute for Health and Care Research (NIHR) and the Wellcome Trust. C. C. T. has received grants from MRC, NIHR, NICHS and Chiesi Farmaceutici. J. C. K. reports grants from Chest Heart and Stroke NI, NIHR, and Mater Hospital YP Trustees."

"This was a randomized double-blind placebo-controlled allocation-concealed clinical trial conducted at Mater Hospital Belfast, Northern Ireland. Trial management, statistical support, and data monitoring and management was facilitated by the Northern Ireland Clinical Trials Unit (NICTU). The trial was sponsored by Belfast Health and Social Care Trust and received approval from the Office of Research Ethics Committees Northern Ireland (Identifier: 18/NI/0106). Clinical trial authorization was granted by Medicines and Healthcare Products Regulatory Agency. The study safety data were monitored every 6 months by an independent data monitoring and ethics committee. The trial was registered prospectively on EudraCT 2017-004686-28 and ClinicalTrials.gov (Identifier: NCT03699904). The trial protocol and statistical analysis plan, completed before data analysis, are available online from NICTU. Patients who were older than 18 years and had a diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria (FEV1 to FVC ratio of < 0.7 after bronchodilator administration) were screened for trial participation. The main inclusion criteria were sputum EBV detection (evaluated by qPCR) and moderate or severe airflow limitation (FEV1 of 30%-80% predicted). Patients were excluded if they had experienced a recent exacerbation (in the previous month) or had a diagnosis of asthma, bronchiectasis (CT scan proven), or interstitial lung disease. Patients continued maintenance COPD therapy. The inclusion and exclusion criteria are detailed in the trial protocol and are available online from NICTU. The trial was conducted in accordance with good clinical practice guidelines and the ethical principles described in the Declaration of Helsinki. All patients provided written informed consent before study entry."