Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single-center, Double-blind, Randomised, Placebo-controlled Crossover Study to Evaluate the Effect of Solithromycin on Airway Inflammation in Male and Female Patients With Chronic Obstructive Pulmonary Disease
This study examines the potential benefit of a new antibiotic, Solithromycin, for the long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD patients will receive treatment with solithromycin for 28 days and comparisons will be made between any effects observed with Solithromycin and a placebo. This will include any changes in inflammatory proteins, lung function and reported symptoms.
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.
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