RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa

• IRAS ID

  60620

• Contact name

  Adam T Hill

• Sponsor organisation

  NHS Lothian

• Eudract number

  2010-022042-24

• Research summary

  Statins are a class of drug used to prevent heart attacks and strokes by lowering blood cholesterol levels. They have also been found to have a beneficial "side effect" of lowering the level of inflammation in the body. This is thought to be one of the reasons they are effective in treating heart attacks and strokes. Laboratory experiments have shown that statins reduce lung inflammation in response to bacteria and this is a promising development for the treatment of chest infections. Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum production and recurrent chest infections. 2/3 of patients are chronically colonised with bacteria (normally the lungs are sterile) and this leads inflammation in the lung and in the rest of the body. There are no effective treatments for bronchiectasis other than antibiotics for chest infections. With increasing antibiotic use, there is increasing antibiotic resistance and new treatments for this disease are needed. We intend to study Atorvastatin in patients with bronchiectasis with colonization with pseudomonas aeruginosa. We will give Atorvastatin to 16 patients with this disease while 16 patients will receive placebo. This will be a crossover study where patients will receive atorvastatin or placebo for 3 months, followed by a wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving atorvastatn will now receive placebo and those receiving placebo will receive atorvastatin for 3 months. We will measure inflammation in their lungs and in the rest of their body before at baseline, 3 months, 4.5 months and at 7.5 months. We will also assess their quality of life and number of chest infections over a 7.5 month period. This pilot study will determine if there is any role for statins are an anti-inflammatory agent in patients with bronchiectasis.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/65

• Date of REC Opinion

  28 Oct 2010

• REC opinion

  Further Information Favourable Opinion