A study to evaluate the effect of solithromycin in COPD
Research type
Research Study
Full title
A single-centre, 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.
IRAS ID
154499
Contact name
Craig Michael Batista
Contact email
Sponsor organisation
Imperial College, London
Eudract number
2014-003077-42
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a common debilitating respiratory illness, killing around 30,000 people annually in the UK and inflicting many more with severely-limiting symptoms. The primary risk factor is cigarette smoking, which causes inflammation and progressive lung destruction. Medicines for this disease are limited and unable to effectively combat inflammation or halt disease progression. Even steroids (normally potent anti-inflammatories) have little or no effect in COPD. The presence of low levels of bacteria in the airways of a third of COPD patients perpetuates inflammation further.
A group of antibiotics, known as macrolides, are occasionally used as a supplementary long-term treatment for COPD. They remove bacteria, dampen inflammation and improve symptoms. In addition, macrolides are also capable of direct anti-inflammatory actions by improving the function of cells that remove bacteria. However, concerns over bacterial resistance have prevented their widespread acceptance.
Solithromycin is a novel macrolide manufactured by Cempra Pharmaceuticals, who are funding this study, which potently kills many types of bacteria. It also possesses superior anti-inflammatory effects (10-fold greater than other macrolides) and can improve the sensitivity of cells to steroids. Importantly, to date, bacteria are unable to develop resistance to solithromycin.
1000 adults have already safely received solithromycin in completed studies, which have demonstrated its safety and effectiveness for the treatment of pneumonia and gonorrhoea. This study will assess the effect of solithromycin as an anti-inflammatory treatment for COPD. 30 patients will be recruited from Harefield hospital to receive 28 days of solithromycin or a dummy pill called a placebo, followed by a 28 day break, before taking the alternative course of tablets. Effects on the levels of inflammatory cells and inflammatory proteins will be periodically measured in samples of phlegm, blood and nasal lining fluid. Any effects on breathing capacity or quality of life (questionnaire) will also be assessed.
REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/2066
Date of REC Opinion
3 Dec 2014
REC opinion
Favourable Opinion