Effect of ELOM-080 on exacerbations and symptoms in COPD patients with a chronic bronchitis phenotype – A post-hoc analysis of a randomized, double-blind, placebo-controlled clinical trial

International Journal of COPD

Volumn 11, Issue 1, 2016, Pages 2877-2884

  Beeh, Kai Michael ^a   Beier, Jutta ^a   Candler, Henning ^b   Wittig, Thomas ^b  

^a Institut fur Atemwegsforschung INSAF   (Germany)

^b Arzt für Allgemeinmedizin   (Germany)

Author keywords

Chronic bronchitis; COPD; Exacerbations; Myrtol; Phytotherapy; Sputum; Winter

Indexed keywords

ELOM 080; MYRTOL; PLACEBO; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; DRUG COMBINATION; RESPIRATORY TRACT AGENT; TERPENE;

ADULT; AGED; ARTICLE; CHRONIC BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL DISEASE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SPUTUM; TREATMENT OUTCOME; BRONCHITIS, CHRONIC; CLINICAL TRIAL; COMPLICATION; COUGH; DISEASE COURSE; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; GERMANY; LUNG; MIDDLE AGED; MULTICENTER STUDY; PATHOPHYSIOLOGY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEASON; TIME FACTOR; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; BRONCHITIS, CHRONIC; COUGH; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; GERMANY; HEALTH STATUS; HUMANS; LUNG; MALE; MIDDLE AGED; MONOTERPENES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESPIRATORY SYSTEM AGENTS; SEASONS; SPUTUM; TIME FACTORS; TREATMENT OUTCOME;

EID: 85000347769     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S117652     Document Type: Article

References (45)

1. Decramer M. GOLD: Global strategy for the diagnosis, management, and prevention of COPD; 2016 [Updated, 2016]. Available from: www.goldcopd.com
2. Han MK, Agusti A, Calverley PM, et al. Chronic obstructive pulmonary disease phenotypes: the future of COPD. Am J Respir Crit Care Med. 2010;182(5):598-604.
3. Rabe KF, Fabbri LM, Vogelmeier C, et al. Seasonal distribution of COPD exacerbations in the prevention of exacerbations with tiotropium in COPD trial. Chest. 2013;143(3):711-719.
4. Hurst JR, Donaldson GC, Quint JK, Goldring JJ, Baghai-Ravary R, Wedzicha JA. Temporal clustering of exacerbations in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;179(5):369-374.
5. Hurst JR, Vestbo J, Anzueto A, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010;363(12):1128-1138.
6. Kim V, Criner GJ. The chronic bronchitis phenotype in chronic obstructive pulmonary disease: features and implications. Curr Opin Pulm Med. 2015;21(2):133-141.
7. Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014;9:139-150.
8. Hogg JC, Chu FS, Tan WC, et al. Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. Am J Respir Crit Care Med. 2007;176(5):454-459.
9. Hogg JC, Chu F, Utokaparch S, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. 2004;350(26):2645-2653.
10. Vestbo J, Prescott E, Lange P. Association of chronic mucus hypersecretion with FEV1 decline and chronic obstructive pulmonary disease morbidity. Copenhagen City Heart Study Group. Am J Respir Crit Care Med. 1996;153(5):1530-1535.
11. Pistelli R, Lange P, Miller D. Determinants of prognosis of COPD in the elderly: mucus hypersecretion, infections, cardiovascular comorbidity. Eur Respir J Suppl. 2003;21(40 suppl):10s-14s.
12. Burgel PR, Nesme-Meyer P, Chanez P, et al. Cough and sputum production are associated with frequent exacerbations and hospitalizations in COPD subjects. Chest. 2009;135(4):975-982.
13. Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015;385(9971):857-866.
14. Miravitlles M, Soler-Cataluña JJ, Calle M, et al. Spanish COPD Guidelines (GesEPOC): pharmacological treatment of stable COPD. Arch Bronconeumol. 2012;48(7):247-257.
15. Han MK, Tayob N, Murray S, et al. Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy. Am J Respir Crit Care Med. 2014;189(12):1503-1508.
16. Vogelmeier C, Buhl R, Criee CP, et al. [Guidelines for the diagnosis and therapy of COPD issued by Deutsche Atemwegsliga and Deutsche Gesellschaft fur Pneumologie und Beatmungsmedizin]. Pneumologie. 2007;61(5):e1-e40. German.
17. Zheng JP, Kang J, Huang SG, et al. Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): a randomised placebo-controlled study. Lancet. 2008;371(9629):2013-2018.
18. Poole P, Chong J, Cates CJ. Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015;7:Cd001287.
19. Beuscher N, Kietzmann M, Bien E, Champeroux P. Interference of myrtol standardized with inflammatory and allergic mediators. Arzneimittelforschung. 1998;48(10):985-989.
20. Beuscher N, Bien E, Elstner E, Kietzmann M, Amon U. Myrtol standardized in treatment of sinusitis and bronchitis-Pharmacodynamics and pharmacokinetics. Z Phytotherapie Abstractband. 1997;8:9-10.
21. Grassmann J, Hippeli S, Dornisch K, Rohnert U, Beuscher N, Elstner EF. Antioxidant properties of essential oils. Possible explanations for their anti-inflammatory effects. Arzneimittelforschung. 2000;50(2):135-139.
22. App EM. Stellenwert der Mukusclearance für das Bronchialsystem-Pathophysiologie und therapeutische Ansätze. Entzündliche Erkrankungen des Bronchialsystems: Springer; 2000:27-53.
23. Begrow F, Bockenholt C, Ehmen M, Wittig T, Verspohl EJ. Effect of myrtol standardized and other substances on the respiratory tract: ciliary beat frequency and mucociliary clearance as parameters. Adv Ther. 2012;29(4):350-358.
24. Christoph F, Kaulfers PM, Stahl-Biskup E. In vitro evaluation of the antibacterial activity of beta-triketones admixed to Melaleuca oils. Planta Med. 2001;67(8):768-771.
25. Lai Y, Dilidaer D, Chen B, et al. In vitro studies of a distillate of rectified essential oils on sinonasal components of mucociliary clearance. Am J Rhinolo Allergy. 2014;28(3):244-248.
26. Cao L, Chen Y, Zhao Y, et al. Effect of myrtol standardized on mucus hypersecretion and clearance of Pseudomonas aeruginosa in a rat model of chronic obstructive pulmonary disease. Arzneimittelforschung. 2011;61(12):685-692.
27. Ulmer W, Schött D. Chronisch-obstruktive Bronchitis. Wirkung von Gelomyrtol® forte in einer plazebokontrollierten Doppelblindstudie. Fortschr Med. 1991;109(27):547-550. German.
28. Gillissen A, Wittig T, Ehmen M, Krezdorn H, de Mey C. A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol® forte in acute bronchitis. Drug Res (Stuttg). 2013;63(01):19-27.
29. Meister R, Wittig T, Beuscher N, de Mey C. Efficacy and tolerability of myrtol standardized in long-term treatment of chronic bronchitis. a double-blind, placebo-controlled study. Study Group Investigators. Arzneimittelforschung. 1999;49(4):351-358.
30. Matthys H, de Mey C, Carls C, Rys A, Geib A, Wittig T. Efficacy and tolerability of myrtol standardized in acute bronchitis. a multi-centre, randomised, double-blind, placebo-controlled parallel group clinical trial versus cefuroxime and ambroxol. Arzneimittelforschung. 2000;50(8):700-711.
31. WHO. Report of an expert committee: Definition and diagnosis of pulmonary disease with special reference to chronic bronchitis and emphysema. WHO Techn Rep Ser. 1961;213(1961):14-19.
32. Santos S, Marin A, Serra-Batlles J, et al. Treatment of patients with COPD and recurrent exacerbations: the role of infection and inflammation. Int J Chron Obstruct Pulmon Dis. 2016;11:515-525.
33. Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177(1):19-26.
34. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011;364(12):1093-1103.
35. Molyneaux PL, Mallia P, Cox MJ, et al. Outgrowth of the bacterial airway microbiome after rhinovirus exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013;188(10):1224-1231.
36. Vestbo J, Lange P. Prevention of COPD exacerbations: medications and other controversies. ERJ Open Res. 2015;1(1):00011-2015.
37. Seemungal T, Harper-Owen R, Bhowmik A, et al. Respiratory viruses, symptoms, and inflammatory markers in acute exacerbations and stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001;164(9):1618-1623.
38. Stockley RA, O’Brien C, Pye A, Hill SL. Relationship of sputum color to nature and outpatient management of acute exacerbations of COPD. Chest. 2000;117(6):1638-1645.
39. Bafadhel M, McKenna S, Terry S, et al. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011;184(6):662-671.
40. Wedzicha JA, Decramer M, Seemungal TA. The role of bronchodilator treatment in the prevention of exacerbations of COPD. Eur Respir J. 2012;40(6):1545-1554.
41. Calverley PM, Rabe KF, Goehring U-M, Kristiansen S, Fabbri LM, Martinez FJ. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374(9691):685-694.
42. Poole P, Black PN, Cates CJ. Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;8:CD001287.
43. Society AT. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995;152(5 Pt 2):S78-S121.
44. Anthonisen N, Manfreda J, Warren C, Hershfield E, Harding G, Nelson N. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106(2):196-204.
45. Effing TW, Kerstjens HA, Monninkhof EM, et al. Definitions of exacerbations: does it really matter in clinical trials on COPD? Chest. 2009;136(3):918-923.