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In adults with acute exacerbations of asthma, giving azithromycin in addition to standard care produced no statistically significant or clinically important benefit

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Sebastian L Johnston 1,*, Matyas Szigeti 2, Mary Cross 2, Christopher Brightling 3, Rekha Chaudhuri 4,5, Timothy Harrison 6, Adel Mansur 7,8, Laura Robison 2, Zahid Sattar 2, David Jackson 1, Patrick Mallia 1, Ernie Wong 1, Christopher Corrigan 9,10, Bernard Higgins 11, Philip Ind 1,12, Dave Singh 13, Neil Thomson 4, Deborah Ashby 2, Anoop Chauhan 14

1 National Heart and Lung Institute, Imperial College London, London, UK
2 Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
3 Institute for Lung Health, University of Leicester, Leicester, UK
4 Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
5 Respiratory Medicine, NHS Greater Glasgow and Clyde, Glasgow, UK
6 Nottingham Respiratory Research Unit, University of Nottingham, Nottingham, UK
7 Respiratory Medicine, Heart of England NHS Foundation Trust, Birmingham, UK
8 Severe and Brittle Asthma Unit, University of Birmingham, Birmingham, UK
9 Department of Respiratory Medicine and Allergy, School of Medicine, King’s College London, London, UK
10 Department of Asthma, Allergy and Respiratory Science, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
11 Respiratory Medicine, Newcastle University, Newcastle, UK
12 Respiratory Medicine, Imperial College Healthcare NHS Trust, London, UK
13 Medicines Evaluation Unit (MEU), University of Manchester, Manchester, UK
14 Respiratory Medicine, Portsmouth Hospitals NHS Trust, Portsmouth, UK
* Corresponding author Email: s.johnston@imperial.ac.uk

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Responses to this report

Response by Professor Sebastian L. Johnston on 15 May 2018 at 5:55 PM
Correction of adverse event data inaccuracies for the AZALEA study
We would like to inform readers that we have discovered small data inaccuracies in the AZALEA manuscript. Due to an error in the clinical trial database, we have determined that we erroneously reported 220 adverse events whereas the actual number was 218. The following identifies the text changes that are needed to correct these errors. Page 46: “Table 34 provides further detail about the distribution of the 220 AEs between the 103 patients who reported AEs.” Should be: “Table 34 provides further detail about the distribution of the 218 AEs between the 103 patients who reported AEs.” Page 48, Table 31: “Respiratory, thoracic and mediastinal disorders Active/Placebo/Total: 27/37/64” should be: Active/Placebo/Total: 26/36/62 and “Total 106/114/220” should be: Total 105/113/218 Page 48, Table 32: “Respiratory, thoracic and mediastinal disorders Active/Placebo/Total: 20/28/48” should be: Active/Placebo/Total: 20/27/47, and “Total number of adverse events (number of patients affected) 85 (51) 92 (52) 177 (103) should be: 85 (51) / 91 (51) / 176 (103) Page 49, Table 33: “Respiratory, thoracic and mediastinal disorders 49/14/0/0/1/64” should be: 48/14/0/0/0/62 Page 49, Table 34: numbers for 2 adverse events changes from: 12/9/21 to: 13/9/22 and for 3 adverse events from: 7/6/13 to: 6/6/12. Page 55: “Interestingly, there was a similar reduction in respiratory, thoracic and mediastinal AEs in the azithromycin group (27 events) as in the placebo group (37 events). A total of 63 of these 64 events proved to be respiratory (the other was backache), suggesting that antibiotic therapy possibly reduced the level of respiratory AEs in this population.” Should read: “Interestingly, there was a similar reduction in respiratory, thoracic and mediastinal AEs in the azithromycin group (26 events) as in the placebo group (37 events). A total of 61 of these 62 events proved to be respiratory (the other was backache), suggesting that antibiotic therapy possibly reduced the level of respiratory AEs in this population.”

 

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