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Original Research |

A randomised control trial of atorvastatin in bronchiectasis patients infected with Pseudomonas aeruginosa- a proof of concept study OPEN ACCESS

Pallavi Bedi, MD; James D. Chalmers, PhD; Catriona Graham, MSc; Andrea Clarke, MSc; Samantha Donaldson, BSc; Catherine Doherty, PhD; John RW. Govan, DSc; Donald J. Davidson, PhD; Adriano G. Rossi, DSc; Adam T. Hill, MD
Author and Funding Information

This study is registered with ClinicalTrials.gov, number NCT01299194.

Contribution of authors:

PB conducted the study, performed the in vitro experiments, analysed the data and wrote the manuscript.

DJD contributed to experimental development, interpretation of data and writing of the manuscript.

JDC and JRWG contributed in writing the manuscript.

CG analysed the study and contributed in writing the manuscript.

AC and SD contributed in data collection and in writing the manuscript.

CD helped with microbiology procedures and contributed in writing the manuscript.

AGR contributed in study design, experiment protocols, in vitro experiments and in writing the manuscript.

ATH contributed in study design, analysis, data interpretation and in writing the manuscript.

1University of Edinburgh / MRC Centre for Inflammation Research, Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK

2School of Medicine, University of Dundee, Dundee, UK

3Wellcome Trust Clinical Research Facility, University of Edinburgh, Western General Hospital, Edinburgh, UK

4Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, UK

5Cystic Fibrosis Laboratory, Centre for Infectious Diseases, Edinburgh, UK

Address for correspondence: Dr Pallavi Bedi MRC Centre for Inflammation Research, Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ.


Copyright 2017, . All Rights Reserved.


Chest. 2017. doi:10.1016/j.chest.2017.05.017
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Abstract

Introduction  There are no randomised control trials of statin therapy in patients with severe bronchiectasis, chronically infected with Pseudomonas aeruginosa.

Methods  32 patients chronically infected with P. aeruginosa were recruited in this double blind cross over RCT. 16 patients were recruited in each arm, given atorvastatin 80mg or placebo for 3months, followed by a washout period for 6weeks, crossed over and administered the alternative therapy for 3months.

Results  27 patients completed the study. Atorvastatin did not significantly improve the primary endpoint of cough as measured by Leicester Cough Questionnaire [mean difference=1.92, 95% CI for difference (-0.57, 4.41), p=0.12]. However, atorvastatin treatment resulted in improved St Georges Respiratory Questionnaire (-5.62points, p=0.016), reduced serum CXCL8 (p=0.04), TNF (p=0.01) and ICAM1 (p=0.04). There was a trend towards improvement in serum CRP and serum neutrophil counts (p=0.07 and p=0.06 respectively).In vitro, we demonstrated that atorvastatin 10μM reduced fMLF induced upregulation of CD11b expression and changes in calcium flux reflecting an ability to decrease neutrophil activation.

Conclusion  We demonstrated that atorvastatin reduced systemic inflammation and improved quality of life in bronchiectasis patients infected with P. aeruginosa. These effects may be due to an ability of atorvastatin to modulate neutrophil activation.


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