Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial

• Status: Terminated
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belfast Health and Social Care Trust
• Collaborators: Northern Ireland Clinical Trials Unit; Queen's University, Belfast
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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. 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.

13. 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).