A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesise that long term statin treatment will improve patients' symptoms through its anti-inflammatory effect. The beneficial effects on patient symptoms (cough, sputum volume, bacterial load, airway function, exercise tolerance, exacerbation frequency and health related quality of life) will be consequent on reduced neutrophilic airways inflammation.

• 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 18-75 will be recruited. All will have an established radiological diagnosis of bronchiectasis (CT of the chest). Patients will have clinically significant bronchiectasis expectorating mucopurulent or purulent sputum when clinically stable with at least 2 chest infections per year.

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

• patients on long term oral macrolides due to the interaction with statin therapy patients chronically colonised with Pseudomonas aeruginosa (defined as two or more isolates of Pseudomonas aeruginosa whilst clinically stable in 6 months prior to the study).