Azithromycin maintenance treatment in patients with frequent exacerbations of chronic obstructive pulmonary disease (COLUMBUS): A randomised, double-blind, placebo-controlled trial

The Lancet Respiratory Medicine

Volumn 2, Issue 5, 2014, Pages 361-368

  Uzun, Sevim ^a   Djamin, Remco S ^a   Kluytmans, Jan A J W ^a   Mulder, Paul G H ^a   van't Veer, Nils E ^a   Ermens, Anton A M ^a   Pelle, Aline J ^b   Hoogsteden, Henk C ^c   Aerts, Joachim G J V ^a,c   Van der Eerden, Menno M ^c  

^a AMPHIA HOSPITAL   (Netherlands)

^b TILBURG UNIVERSITY   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; AZITHROMYCIN; CREATININE; GAMMA GLUTAMYLTRANSFERASE; LACTATE DEHYDROGENASE; PLACEBO; PREDNISOLONE; ANTIINFECTIVE AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG WITHDRAWAL; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL DISEASE; HAEMOPHILUS INFLUENZAE; HOSPITAL ADMISSION; HUMAN; HYPERCHLOREMIA; LACTATE DEHYDROGENASE BLOOD LEVEL; LOW DRUG DOSE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NAUSEA; NETHERLANDS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDOMONAS AERUGINOSA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STREPTOCOCCUS PNEUMONIAE; UNSPECIFIED SIDE EFFECT; UREA NITROGEN BLOOD LEVEL; VOMITING; AGED; DISEASE COURSE; MAINTENANCE CHEMOTHERAPY; PROCEDURES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RECURRENT DISEASE; TREATMENT OUTCOME;

AGED; ANTI-BACTERIAL AGENTS; AZITHROMYCIN; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RECURRENCE; TREATMENT OUTCOME;

EID: 84900301838     PISSN: 22132600     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2213-2600(14)70019-0     Document Type: Article

References (37)

1. Suissa S, Dell'Aniello S, Ernst P Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax 2012, 67:957-963.
2. Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005, 60:925-931.
3. Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998, 157:1418-1422.
4. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002, 57:847-852.
5. Kanoh S, Rubin BK Mechanisms of action and clinical application of macrolides as immunomodulatory medications. Clin Microbiol Rev 2010, 23:590-615.
6. Albert RK, Connett J, Bailey WC, et al. Azithromycin for prevention of exacerbations of COPD. N Engl J Med 2011, 365:689-698.
7. Serisier DJ Risks of population antimicrobial resistance associated with chronic macrolide use for inflammatory airway diseases. Lancet Respir Med 2013, 1:262-274.
8. Wenzel RP, Fowler AA, Edmond MB Antibiotic prevention of acute exacerbations of COPD. N Engl J Med 2012, 367:340-347.
9. Uzun S, Djamin RS, Kluytmans J, et al. Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): study protocol for a randomised controlled trial. Trials 2012, 13:82.
10. Rabe KF, Hurd S, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2007, 176:532-555.
11. Isenberg HD Clinical microbiology procedures handbook 2004, American Society of Microbiology Press, Washington DC. 2nd edn.
12. Clinical breakpoints European Committee on Antimicrobial Susceptibility Testing (EUCAST), (accessed Oct 10, 2013). http://www.eucast.org/clinical_breakpoints/.
13. Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987, 106:196-204.
14. Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med 2008, 178:1139-1147.
15. Banerjee D, Khair OA, Honeybourne D The effect of oral clarithromycin on health status and sputum bacteriology in stable COPD. Respir Med 2005, 99:208-215.
16. He ZY, Ou LM, Zhang JQ, et al. Effect of 6 months of erythromycin treatment on inflammatory cells in induced sputum and exacerbations in chronic obstructive pulmonary disease. Respiration 2010, 80:445-452.
17. Blasi F, Bonardi D, Aliberti S, et al. Long-term azithromycin use in patients with chronic obstructive pulmonary disease and tracheostomy. Pulm Pharmacol Ther 2010, 23:200-207.
18. Suzuki T, Yanai M, Yamaya M, et al. Erythromycin and common cold in COPD. Chest 2001, 120:730-733.
19. Clement A, Tamalet A, Leroux E, Ravilly S, Fauroux B, Jais JP Long term effects of azithromycin in patients with cystic fibrosis: a double blind, placebo controlled trial. Thorax 2006, 61:895-902.
20. Saiman L, Marshall BC, Mayer-Hamblett N, et al. Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial. JAMA 2003, 290:1749-1756.
21. Miravitlles M, Ferrer M, Pont A, et al. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax 2004, 59:387-395.
22. Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet 2007, 369:482-490.
23. Hahn DL Azithromycin for prevention of exacerbations of COPD. N Engl J Med 2011, 365:2236. 2236.
24. Wong C, Jayaram L, Karalus N, et al. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet 2012, 380:660-667.
25. Altenburg J, de Graaff CS, Stienstra Y, et al. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA 2013, 309:1251-1259.
26. Serisier DJ, Martin ML, McGuckin MA, et al. Effect of long-term, low-dose erythromycin on pulmonary exacerbations among patients with non-cystic fibrosis bronchiectasis: the BLESS randomized controlled trial. JAMA 2013, 309:1260-1267.
27. Martinez-Garcia MA, Soler-Cataluna JJ, Donat Sanz Y, et al. Factors associated with bronchiectasis in patients with COPD. Chest 2011, 140:1130-1137.
28. Donaldson GC, Mullerova H, Locantore N, et al. Factors associated with change in exacerbation frequency in COPD. Respir Res 2013, 14:79.
29. Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010, 363:1128-1138.
30. Beeh KM, Glaab T, Stowasser S, et al. Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial. Respir Res 2013, 14:116.
31. Suzuki T, Yamaya M, Sekizawa K, et al. Erythromycin inhibits rhinovirus infection in cultured human tracheal epithelial cells. Am J Respir Crit Care Med 2002, 165:1113-1118.
32. Marjanovic N, Bosnar M, Michielin F, et al. Macrolide antibiotics broadly and distinctively inhibit cytokine and chemokine production by COPD sputum cells in vitro. Pharmacol Res 2011, 63:389-397.
33. Hodge S, Hodge G, Jersmann H, et al. Azithromycin improves macrophage phagocytic function and expression of mannose receptor in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2008, 178:139-148.
34. Halldorsson S, Gudjonsson T, Gottfredsson M, Singh PK, Gudmundsson GH, Baldursson O Azithromycin maintains airway epithelial integrity during Pseudomonas aeruginosa infection. Am J Respir Cell Mol Biol 2010, 42:62-68.
35. Marin A, Garcia-Aymerich J, Sauleda J, et al. Effect of bronchial colonisation on airway and systemic inflammation in stable COPD. COPD 2012, 9:121-130.
36. Nahata M Drug interactions with azithromycin and the macrolides: an overview. J Antimicrob Chemother 1996, 37(suppl C):133-142.
37. Brusselle GG, Vanderstichele C, Jordens P, et al. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax 2013, 68:322-329.