Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: A review

Medical Devices: Evidence and Research

Volumn 4, Issue 1, 2011, Pages

  VanDevanter, Donald R ^a   Geller, David E ^b  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NEMOURS CHILDREN S HOSPITAL   (United States)

Author keywords

Cystic fibrosis; Dry powder inhaler; Tobramycin

Indexed keywords

ARTIFICIAL INTELLIGENCE; BIOLOGICAL ORGANS; DEPOSITION; GAS COMPRESSORS; PATIENT TREATMENT;

CYSTIC FIBROSIS; DEVICE COMPLEXITY; DRY POWDER INHALER; PATIENT SATISFACTION; PSEUDOMONAS AERUGINOSA; PULMONARY FUNCTION; REDUCING TREATMENT; TOBRAMYCIN;

ANTIBIOTICS;

ANTIBIOTIC AGENT; PLACEBO; QUINOLINE DERIVED ANTIINFECTIVE AGENT; TOBRAMYCIN;

ACUTE KIDNEY FAILURE; AEROSOL; ANTIBIOTIC THERAPY; BRONCHOSPASM; CHRONIC DISEASE; CLINICAL EFFECTIVENESS; COMPARATIVE EFFECTIVENESS; COUGHING; CYSTIC FIBROSIS; DOSE RESPONSE; DRUG ADMINISTRATION ROUTE; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPHONIA; EOSINOPHILIA; EVIDENCE BASED MEDICINE; HUMAN; LUNG INFECTION; LUNG VOLUME; MULTIPLE CYCLE TREATMENT; NEBULIZER; NONHUMAN; PATIENT SATISFACTION; PEAK INSPIRATORY FLOW; POWDER INHALER; PROCESS DEVELOPMENT; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; QUALITY OF LIFE; REVIEW; TINNITUS;

EID: 84889073216     PISSN: None     EISSN: 11791470     Source Type: Journal    
DOI: 10.2147/MDER.S16360     Document Type: Review

References (88)

1. Davis PB, Drumm M, Konstan M W. Cystic fibrosis. Amer J Respir Crit Care Med. 1996;154(5):1229-1256.
2. Ratjen F, Döring G. Cystic fibrosis. Lancet. 2003;361(9358):681-689.
3. National Newborn Screening and Genetics Resource Center. National Newborn Screening Report: 2000. San Antonio, TX: National Newborn Screening and Genetics Resource Center; 2003. Available at http:// genes-r-us.uthscsa.edu/resources/newborn/00/2000report.pdf. Accessed Aug 19, 2011.
4. Cystic Fibrosis Mutation Database. CFMDB statistics [web page on the Internet]. Toronto: Cystic Fibrosis Centre at the Hospital for Sick Children; and [updated Apr 25, 2011]. Available from: http://genet.sick-kids.on.ca/StatisticsPage.html. Accessed Aug 19, 2011.
5. European Cystic Fibrosis Society. ECFS Patient Registry Report 2007 Data. Karup: European Cystic Fibrosis Society; 2010. Available at: http://www.ecfs.eu/fles/webfm/webfles/File/ecfs_registry/ECFRreport 2007fnal.pdf. Accessed Aug 19, 2011.
6. Cystic Fibrosis Trust. UK CF Registry Annual Data Report 2009. Bromley, London: Cystic Fibrosis Trust; 2011. Available at: http://www.cftrust.org.uk/aboutcf/publications/cfregistryreports/Final_UK_ Cystic_Fibrosis_Registry_Report_2009.pdf. Accessed Aug 19, 2011.
7. Cystic Fibrosis Canada. Canadian Cystic Fibrosis Patient Data Registry Report: 2009. Toronto: Cystic Fibrosis Canada; 2011. Available at: http://www.cysticfibrosis.ca/assets/fles/pdf/CPDR_ReportE.pdf. Accessed Aug 19, 2011.
8. Cystic Fibrosis Australia. Cystic fibrosis in Australia 2009: 12th Annual Report from the Australian Cystic Fibrosis Data Registry. North Ryde: Cystic Fibrosis Australia; 2011. Available at: http://www.cysticfibrosis.org.au/projects/dataregistry/. Accessed Aug 19, 2011.
9. Cystic Fibrosis Foundation. Patient Registry: Annual Data Report 2009. Bethesda, MD: Cystic Fibrosis Foundation; 2010. Available at: http://www.cff.org/UploadedFiles/research/ClinicalResearch/Patient-Registry-Report-2009.pdf. Accessed Aug 19, 2011.
10. Donaldson SH, Boucher RC. Update on pathogenesis of cystic fibrosis lung disease. Curr Opin Pulm Med. 2003;9(6):486-491.
11. Knowles MR, Gilligan PH, Boucher RC. Cystic fibrosis. In: Mandell GL, Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Vol 1. 5th ed. Philadelphia, PA: Churchill Livingstone; 2000:767-772.
12. Konstan M W, Berger M. Infection and infammation in the lung in cystic fibrosis. In: Davis PB, editor. Cystic Fibrosis. New York, NY: Marcel Dekker; 1993:219-276.
13. Lipuma JJ. The changing microbial epidemiology in cystic fibrosis. Clin Microbiol Rev. 2010;23(2):299-323.
14. Gilligan PH. Microbiology of airway disease in patients with cystic fibrosis. Clin Microbiol Rev. 1991;4(1):35-51.
15. Govan JR, Nelson JW. Microbiology of lung infection in cystic fibrosis. Br Med Bull. 1992;48(4):912-930.
16. Govan JR, Deretic V. Microbial pathogenesis in cystic fibrosis: mucoid Pseudomonas aeruginosa and Burkholderia cepacia. Microbiol Rev. 1996;60(3):539-574.
17. Høiby N, Flensborg E W, Beck B, Friis B, Jacobsen S V, Jacobsen L. Pseudomonas aeruginosa infection in cystic fibrosis: diagnostic and prognostic significance of Pseudomonas aeruginosa precipitins determined by means of crossed immune electrophoresis. Scand J Respir Dis. 1977;58(2):65-79.
18. Henry RL, Mellis CM, Petrovic L. Mucoid Pseudomonas aeruginosa is a marker of poor survival in cystic fibrosis. Pediatr Pulmonol. 1992;12(3):158-161.
19. Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatr Pulmonol. 2002;34(2):91-100.
20. Pedersen SS, Høiby N, Espersen F, Koch C. Role of alginate in infection with mucoid Pseudomonas aeruginosa in cystic fibrosis. Thorax. 1992;47(1):6-13.
21. Demko CA, Byard PJ, Davis PB. Gender differences in cystic fibrosis: Pseudomonas aeruginosa infection. J Clin Epidemiol. 1995;48(8): 1041-1049.
22. Li Z, Kosorok MR, Farrell PM, et al. Longitudinal development of mucoid Pseudomonas aeruginosa infection and lung disease progression in children with cystic fibrosis. JAMA. 2005;293(5):581-588.
23. Flume PA, O'Sullivan B P, Robinson KA, et al. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2007;176(10):957-969.
24. Burns JL, Ramsey B W, Smith AL. Clinical manifestations and treatment of pulmonary infections in cystic fibrosis. Adv Pediatr Infect Dis. 1993;8:53-66.
25. Marks MI. Antibiotic therapy for bronchopulmonary infections in cystic fibrosis. The American approach. Antibiot Chemother. 1989;42:229-236.
26. Ramsey B W. Management of pulmonary disease in patients with cystic fibrosis. N Engl J Med. 1996;335(3):179-188.
27. Denton M, Wilcox MH. Antimicrobial treatment of pulmonary colonization and infection by Pseudomonas aeruginosa in cystic fibrosis patients. J Antimicrob Chemother. 1997;40(4):468-474.
28. Ferkol T, Rosenfeld M, Milla CE. Cystic fibrosis pulmonary exacerbations. J Pediatr. 2006;148(2):259-264.
29. Flume PA, Mogayzel PJ, Robinson KA, et al. Cystic fibrosis pulmonary guidelines: treatment of pulmonary exacerbations. Am J Respir Crit Care Med. 2009;180(9):802-808.
30. Döring G, Conway S P, Heijerman HG, et al. Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus. Eur Respir J. 2000;16(4):749-767.
31. MacLusky IB, Gold R, Corey M, Levison H. Long-term effects of inhaled tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Pediatr Pulmonol. 1989;7(1):42-48.
32. Ramsey B W, Pepe MS, Quan JM, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999;340(1):23-30.
33. Høiby N. Prospects for the prevention and control of pseudomonal infection in children with cystic fibrosis. Paediatr Drugs. 2000;2(6):451-463.
34. Moss RB. Administration of aerosolized antibiotics in cystic fibrosis patients. Chest. 2001;120(3 Suppl):107S-113S.
35. Quittner AL, Buu A. Effects of tobramycin solution for inhalation on global ratings of quality of life in patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatr Pulmonol. 2002;33(4): 269-276.
36. Murphy TD, Anbar RD, Lester LA, et al. Treatment with tobramycin solution for inhalation reduces hospitalizations in young CF subjects with mild lung disease. Pediatr Pulmonol. 2004;38(4):314-320.
37. Oermann CM, Retsch-Bogart GZ, Quittner AL, et al. An 18-month study of the safety and effcacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatr Pulmonol. 2010;45(11):1121-1134.
38. Konstan M W, VanDevanter DR, Rasouliyan L, et al. Trends in the use of routine therapies in cystic fibrosis: 1995-2005. Pediatr Pulmonol. 2010;45(12):1167-1172.
39. Szaff M, Høiby N, Flensborg E W. Frequent antibiotic therapy improves survival of cystic fibrosis patients with chronic Pseudomonas aeruginosa infection. Acta Paediatr Scand. 1983;72(5):651-657.
40. Elborn JS, Prescott RJ, Stack BH, et al. Elective versus symptomatic antibiotic treatment in cystic fibrosis patients with chronic Pseudomonas infection of the lungs. Thorax. 2000;55(5):355-358.
41. Geller DE. Aerosol antibiotics in cystic fibrosis. Respir Care. 2009; 54(5):658-670.
42. Di Sant'Agnese PE, Andersen DH. Celiac syndrome; chemotherapy in infections of the respiratory tract associated with cystic fibrosis of the pancreas; observations with penicillin and drugs of the sulfonamide group, with special reference to penicillin aerosol. Am J Dis Child. 1946;72:17-61.
43. Hodson ME, Penketh AR, Batten JC. Aerosol carbenicillin and gen-tamicin treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis. Lancet. 1981;2(8256):1137-1139.
44. Kun P, Landau LI, Phelan PD. Nebulized gentamicin in children and adolescents with cystic fibrosis. Aust Paediatr J. 1984;20(1):43-45.
45. Jensen T, Pedersen SS, Garne S, Heilmann C, Høiby N, Koch C. Colistin inhalation therapy in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. J Antimicrob Chemother. 1987;19(6):831-838.
46. Stead RJ, Hodson ME, Batten JC. Inhaled ceftazidime compared with gentamicin and carbenicillin in older patients with cystic fibrosis infected with Pseudomonas aeruginosa. Br J Dis Chest. 1987;81(3):272-279.
47. Carswell F, Ward C, Cook DA, Speller DC. A controlled trial of nebulized aminoglycoside and oral fucloxacillin versus placebo in the outpatient management of children with cystic fibrosis. Br J Dis Chest. 1987;81(4):356-360.
48. Smith AL, Ramsey B W, Hedges DL, et al. Safety of aerosol tobramycin administration for 3 months to patients with cystic fibrosis. Pediatr Pulmonol. 1989;7(4):265-271.
49. Ramsey B W, Dorkin HL, Eisenberg JD, et al. Effcacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993; 328(24):1740-1746.
50. Hodson ME, Gallagher CG, Govan JR. A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis. Eur Respir J. 2002; 20(3):658-664.
51. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008;178(9):921-928.
52. Retsch-Bogart GZ, Quittner AL, Gibson RL, et al. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest. 2009;135(5):1223-1232.
53. Nasr SZ, Sakmar E, Christodoulou E, Eckhardt B P, Streetman DS, Strouse PJ. The use of high resolution computerized tomography (HRCT) of the chest in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis lung disease. Pediatr Pulmonol. 2010;45(5):440-449.
54. Wainwright CE, Quittner AL, Geller DE, et al. Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. J Cyst Fibros. 2011;10(4):234-242.
55. Conway S P. Nebulized antibiotic therapy: the evidence. Chron Respir Dis. 2005;2(1):35-41.
56. Wiesemann HG, Steinkamp G, Ratjen F, et al. Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatr Pulmonol. 1998;25(2):88-92.
57. Ratjen F, Döring G, Nikolaizik WH. Effect of inhaled tobramycin on early Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Lancet. 2001;358(9286):983-984.
58. Ratjen F, Munck A, Kho P, Angyalosi G; ELITE Study Group. Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial. Thorax. 2010;65(4):286-291.
59. Craig WA, Ebert SC. Killing and regrowth of bacteria in vitro: a review. Scand J Infect Dis Suppl. 1990;74:63-70.
60. Levy J, Smith AL, Koup JR, Williams-Warren J, Ramsey B. Disposition of tobramycin in patients with cystic fibrosis: a prospective controlled study. J Pediatr. 1984;105(1):117-124.
61. De Groot R, Smith AL. Antibiotic pharmacokinetics in cystic fibrosis. Differences and clinical significance. Clin Pharmacokinet. 1987; 13(4):228-253.
62. Mendelman PM, Smith AL, Levy J, Weber A, Ramsey B, Davis RL. Aminoglycoside penetration, inactivation, and effcacy in cystic fibrosis sputum. Am Rev Respir Dis. 1985;132(4):761-765.
63. Weber A, Smith A, Williams-Warren J, Ramsey B, Covert DS. Nebulizer delivery of tobramycin to the lower respiratory tract. Pediatr Pulmonol. 1994;17(5):331-339.
64. Eisenberg J, Pepe M, Williams-Warren J, et al. A comparison of peak sputum tobramycin concentration in patients with cystic fibrosis using jet and ultrasonic nebulizer systems. Aerosolized Tobramycin Study Group. Chest. 1997;111(4):955-962.
65. Izquierdo MJ, Gomez-Alamillo C, Ortiz F, et al. Acute renal failure associated with use of inhaled tobramycin for treatment of chronic airway colonization with Pseudomonas aeruginosa. Clin Nephrol. 2006;66(6):464-467.
66. Santos R P, Awa E, Anbar RD. Inhaled tobramycin solution-associated recurrent eosinophilia and severe persistent bronchospasm in a patient with cystic fibrosis: a case report. BMC Pediatr. 2007;7:11.
67. Standaert TA, VanDevanter DR, Ramsey B W, et al. The choice of compressor affects the aerosol parameters and the delivery of tobramycin from a single model nebulizer. J Aerosol Med. 2000;13(2):147-153.
68. Westerman EM, Boer AH, Touw DJ, et al. Aerosolization of tobramycin (TOBI) with the PARI LC PLUS reusable nebulizer: which compressor to use? Comparison of the CR60 to the PortaNeb compressor. J Aerosol Med Pulm Drug Deliv. 2008;21(3):269-280.
69. Dopfer R, Brand P, Müllinger B et al. Inhalation of tobramycin in patients with cystic fibrosis: comparison of two methods. J Physiol Pharmacol. 2007;58 Suppl 5(Pt 1):141-154.
70. Geller DE, Rosenfeld M, Waltz DA, Wilmott RW; AeroDose TOBI Study Group. Efficiency of pulmonary administration of tobramycin solution for inhalation in cystic fibrosis using an improved drug delivery system. Chest. 2003;123(1):28-36.
71. Hubert D, Leroy S, Nove-Josserand R, et al. Pharmacokinetics and safety of tobramycin administered by the PARI eFlow rapid nebulizer in cystic fibrosis. J Cyst Fibros. 2009;8(5):332-337.
72. Coates AL, Denk O, Leung K, et al. Higher tobramycin concentration and vibrating mesh technology can shorten antibiotic treatment time in cystic fibrosis. Pediatr Pulmonol. 2011;46(4):401-408.
73. Lenoir G, Antypkin YG, Miano A, et al. Effcacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Paediatr Drugs. 2007;9 Suppl 1:11-20.
74. Chuchalin A, Csiszér E, Gyurkovics K, et al. A formulation of aerosolized tobramycin (Bramitob) in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection: a double-blind, placebo-controlled, multicenter study. Paediatr Drugs. 2007;9 Suppl 1: 21-31.
75. Poli G, Acerbi D, Pennini R, et al. Clinical pharmacology study of Bramitob, a tobramycin solution for nebulization, in comparison with Tobi. Paediatr Drugs. 2007;9 Suppl 1:3-9.
76. Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere technology. J Aerosol Med Pulm Drug Deliv. 2011;24(4):175-182.
77. Konstan MW, Geller DE, Minić P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: the EVOLVE trial. Pediatr Pulmonol. 2011;46(3):230-238.
78. Standaert TA, Speirs RJ, Rao N, et al. Young cystic fibrosis patients can effectively use a novel high-payload capsule-based dry powder inhaler with tobramycin powder for inhalation (TPI). Pediatr Pulmonol. 2004;38(Suppl 27):67-91.
79. Tiddens HA, Geller DE, Challoner P, et al. Effect of dry powder inhaler resistance on the inspiratory fow rates and volumes of cystic fibrosis patients of six years and older. J Aerosol Med. 2006; 19(4): 456-465.
80. Haynes A, Nakamura J, Heng C, Heuerding S, Thompson G, Malcolmson R. Aerosol performance of tobramycin inhalation powder. In: Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ, Young PM, editors. Respiratory Drug Delivery 2010. River Grove, IL: Davis Healthcare International; 2008: 701-706.
81. Challoner PB, Flora MG, Hirst PH, et al. Gamma scintigraphy lung deposition comparison of TOBI in the PARI LC Plus nebulizer and the Aerodose inhaler. Am J Respir Crit Care Med. 2001;163:A83.
82. Newhouse MT, Hirst PH, Duddu S P, et al. Inhalation of a dry powder tobramycin pulmosphere formulation in healthy volunteers. Chest. 2003;124(1):360-366.
83. Geller DE, Konstan MW, Smith J, Noonberg SB, Conrad C. Novel Tobramycin inhalation powder in cystic fibrosis subjects: pharmacoki-netics and safety. Pediatr Pulmonol. 2007;42(4):307-313.
84. Geller DE, Pitlick WH, Nardella PA, Tracewell WG, Ramsey B W. Pharmacokinetics and bioavailability of aerosolized tobramycin in cystic fibrosis. Chest. 2002;122(1):219-226.
85. Weber A, Williams-Warren J, Ramsey B, Smith AL. Tobramycin serum concentrations after aerosol and oral administration in cystic fibrosis. Am J Ther. 1995;2(2):81-87.
86. Geller DE, Rosenfeld M, Waltz DA, Wilmott RW; AeroDose TOBI Study Group. Efficiency of pulmonary administration of tobramycin solution for inhalation in cystic fibrosis using an improved drug delivery system. Chest. 2003;123(1):28-36.
87. Konstan M W, Flume PA, Kappler M, et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J Cystic Fibros. 2011;10(1):54-61.
88. Gibson RL, Emerson J, Mayer-Hamblett N, et al. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatr Pulmonol. 2007;42(7):610-623.