Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

The investigators intend to study Atorvastatin in patients with bronchiectasis with colonization with pseudomonas aeruginosa. The investigators 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 statin wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin for 3 months. The investigators will measure inflammation in their lungs and in the rest of their body before and after treatment with atorvastatin. The investigators 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: NHS Lothian
• Treatments: Anti-Inflammatory Agents; Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Patients aged 18-80 will be recruited.

• All will have an established radiological diagnosis of bronchiectasis (CT of the chest).

• Patients colonised with Pseudomonas Aeruginosa.

• Able to give informed consent.

Exclusion Criteria:

• Current smokers or ex-smokers of less than 1 year; >15 pack year history

• Cystic fibrosis

• Active allergic bronchopulmonary aspergillosis

• Active tuberculosis

• Poorly controlled asthma

• Pregnancy or breast feeding

• Known allergy to statins

• Active malignancy

• Chronic liver disease

• Established cardiovascular or cerebrovascular disease

• Statin use in the last year