Epstein-Barr virus infection in patients with chronic obstructive pulmonary disease.
Conditions
Interventions
Product Name: Valaciclovir 500mg
Pharmaceutical Form: Tablet
INN or Proposed INN: valaciclovir
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceu
Sponsors
Belfast Health and Social Care Trust (BHSCT)
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the safety of valaciclovir in the suppression of Epstein-Barr virus (EBV) in patients with chronic obstructive pulmonary disease (COPD). The study objective is to undertake a randomised double-blind, placebo-controlled (i.e. dummy medication) clinical trial to study whether valaciclovir is safe in patients with COPD and improves important clinical outcomes. ;Primary end point(s): The primary endpoint for this study will be to evaluate the safety of valaciclovir one gram (three times daily for 8 weeks) for the suppression of Epstein-Barr virus in patients with COPD as defined by the incidence of serious adverse reactions (SARs).;Timepoint(s) of evaluation of this end point: Participants will be followed up for 4 weeks following completion of the 8 week treatment (i.e. follow up until week 12). ;Secondary Objective: The secondary objectives are to investigate if valaciclovir has an effect on important clinical parameters (clinical symptoms and lung function) and surrogate markers of biological outcomes in COPD. This will help in the future design of other clinical trials with valaciclovir or with other potential therapeutic agents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical symptoms Lung function (FEV1) EBV quantitative PCR ;Timepoint(s) of evaluation of this end point: Week 8. | — |
Countries
United Kingdom
Contacts
Public ContactJoe Kidney
Belfast Health and Social Care Trust
Outcome results
None listed