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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Muscle Lab, Respiratory Medicine, Harefield Hospital
Harefield, Middlesex, United Kingdom
Number of Sputum Neutrophils Per mL at 28 Days
A number of sputum neutrophils per mL after treatment with solithromycin and placebo.
Time frame: 28 days
Concentrations of Sputum CXCL8 at 28 Days
Concentrations of sputum CXCL8 after treatment with solithromycin and placebo.
Time frame: 28 days
Concentrations of Sputum IL-6 Before and After Treatment With Solithromycin and Placebo at 28 Days
Time frame: 28 days
Concentrations of Sputum MPO Before and After Treatment With Solithromycin and Placebo at 28 Days
Time frame: 28 days
Concentrations of Sputum MMP-9 Before and After Treatment With Solithromycin and Placebo at 28 Days
Time frame: 28 days
Concentrations of Sputum MCP-1 Before and After Treatment With Solithromycin and Placebo.
Time frame: 28 days
Concentrations of Sputum TNF-α Before and After Treatment With Solithromycin and Placebo.
Time frame: 28 days
Concentrations of CXCL8 in Nasal Lining Fluid With Solithromycin and Placebo at 28 Days
Time frame: 28 days
FEV1 After Treatment With Solithromycin and Placebo at 28 Days
Time frame: 28 days
R5-R20 After Treatment at 28 Days
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Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
R5-R20 assessed by impulse oscillometry after treatment with solithromycin and placebo.
Time frame: 28 days
COPD Assessment Test (CAT) Scores
COPD Assessment Test (CAT) scores after treatment with solithromycin and placebo. score of 0-40 to indicate the impact of the disease, the higher score better outcome
Time frame: 28 days
The Number of Adult COPD Patients With Treatment-related Adverse Events, as Assessed by CTCAE v4.0.
Time frame: 28 days