A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a common and debilitating respiratory illness, that kills around 30,000 people annually in the UK. The primary risk factor is cigarette smoking, which causes inflammation in the air passages of the lungs. This inflammation is irreversible and results in progressive lung destruction. Currently, there are no effective anti-inflammatory medications available for COPD. Inhalers remain the mainstay of regular treatment for COPD. Macrolide antibiotics however, are occasionally used as a supplementary treatment for some patients. They have been shown to be anti-inflammatory. However, concerns exist over the development of bacterial resistance to such antibiotics. Consequently they are not widely prescribed for COPD. Solithromycin is a new macrolide antibiotic, which has been shown to possess superior anti-inflammatory properties. Importantly, bacteria are far less likely to develop resistance to this new medication. The current study will assess the effect of solithromycin as an anti-inflammatory treatment for COPD. 30 patients will be recruited to receive 28 days of treatment with solithromycin or placebo, followed by a 28 day wash out period (no study medication), before taking a further 28 days of treatment (the medication not taken first time around, i.e. either solithromycin or placebo). This study is a single-centre (Harefield Hospital), double-blind (study team and patient are not told what treatment they are taking), randomised (order in which solithromycin and placebo are taken), placebo-controlled and has a crossover design (subjects take both solithromycin and placebo separately). Sputum, blood and fluid from the nasal lining will be periodically sampled to examine any effect on the levels of inflammatory cells and proteins during the study. Any changes in lung function parameters or symptoms (COPD Assessment Test) will also be assessed.