Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: A comparative efficacy trial

Journal of Cystic Fibrosis

Volumn 12, Issue 2, 2013, Pages 130-140

  Assael, Baroukh M ^a,m   Pressler, Tacjana ^b   Bilton, Diana ^c   Fayon, Michael ^d   Fischer, Rainald ^e   Chiron, Raphael ^f   LaRosa, Mario ^g   Knoop, Christiane ^h   McElvaney, Noel ⁱ   Lewis, Sandra A ^j   Bresnik, Mark ^k   Montgomery, A Bruce ^j   Oermann, Christopher M ^l  

^a Cystic Fibrosis Center   (Italy)

^b Rigshospitalet   (Denmark)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

^d HÔPITAL PELLEGRIN   (France)

^e LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^f MONTPELLIER UNIVERSITY HOSPITAL   (France)

^g UNIVERSITY OF CATANIA   (Italy)

^h ERASME HOSPITAL   (Belgium)

ⁱ BEAUMONT HOSPITAL   (Ireland)

^j Gilead Sciences   (United States)

^k GILEAD SCIENCES   (United States)

^l BAYLOR COLLEGE OF MEDICINE   (United States)

^m Centro Fibrosi Cistica   (Italy)

more..

Author keywords

Antipseudomonal; Inhaled antibiotics; Pseudomonas aeruginosa; Respiratory exacerbations

Indexed keywords

ANTIBIOTIC AGENT; AZTREONAM LYSINE; COLISTIN; TOBRAMYCIN; ANTIINFECTIVE AGENT; AZTREONAM;

ABDOMINAL PAIN; ABNORMAL RESPIRATORY SOUND; APPETITE; ARTICLE; CHILD; COMPARATIVE STUDY; COUGHING; CYSTIC FIBROSIS; DISEASE EXACERBATION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EXERCISE TOLERANCE; FATIGUE; FEMALE; FORCED EXPIRATORY VOLUME; HEMOPTYSIS; HOSPITALIZATION; HUMAN; LUNG CONGESTION; LUNG CYSTIC FIBROSIS; LUNG FIBROSIS; LUNG FUNCTION; LUNG FUNCTION TEST; MALE; MINIMUM INHIBITORY CONCENTRATION; MULTICENTER STUDY; MULTIDRUG RESISTANCE; NAUSEA; NOSE OBSTRUCTION; OPEN STUDY; OROPHARYNX PAIN; PRESCHOOL CHILD; PSEUDOMONAS INFECTION; RHINORRHEA; SCHOOL CHILD; SIDE EFFECT; SPUTUM ANALYSIS; THORAX PAIN; TREATMENT DURATION; VOMITING; WHEEZING; ADOLESCENT; ADULT; CLINICAL TRIAL; CONTROLLED STUDY; INHALATIONAL DRUG ADMINISTRATION; MICROBIOLOGY; PATHOPHYSIOLOGY; PSEUDOMONAS INFECTIONS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANTI-BACTERIAL AGENTS; AZTREONAM; CHILD; CYSTIC FIBROSIS; FEMALE; HUMANS; MALE; PSEUDOMONAS INFECTIONS; RESPIRATORY FUNCTION TESTS; TOBRAMYCIN; TREATMENT OUTCOME;

EID: 84875842391     PISSN: 15691993     EISSN: 18735010     Source Type: Journal    
DOI: 10.1016/j.jcf.2012.07.006     Document Type: Article

References (24)

1. Flume P.A., O'Sullivan B.P., Robinson K.A., Goss C.H., Mogayzel P.J., Willey-Courand D.B., et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med 2007, 176:957-969.
2. Heijermann H., Westerman E., Conway S., Touw D., Döring G., Working Group Consensus Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: a European consensus. J Cyst Fibros 2009, 8:295-315.
3. US prescribing information TOBI®, tobramycin inhalation solution, USP Available from, Cited, Feb 29 2012. http://www.pharma.us.novartis.com/product/pi/pdf/tobi.pdf.
4. Summary of Product Characteristics (SPC) TOBI® 300mg/5mL nebuliser solution Available from:, Cited, Feb 29 2012. http://www.medicines.org.uk/EMC/medicine/19020/SPC/Tobi+300+mg+5+ml+Nebuliser+Solution/#PRODUCTINFO.
5. Summary of Product Characteristics Bramitob 300mg/4ml nebuliser solution Available from:, Cited, Feb 29 2012. http://www.medicines.org.uk/emc/medicine/21427/SPC/Bramitob+Nebuliser+Solution/.
6. Summary of Product Characteristics (SPC) Promixin® 1MIU powder for nebuliser solution Available from:, Cited, Feb 29 2012. http://www.medicines.org.uk/EMC/medicine/13495/SPC/Promixin+1+million+International+Units+(IU)+Powder+for+Nebuliser+Solution/.
7. Prescribing Information U.S. Cayston® (aztreonam for inhalation solution) Available from, Cited, Sept 27 2011. https://www.cayston.com/assets/media/pdfs/CAYSTON_full_prescribing_information.pdf.
8. Summary of Product Characteristics (SPC) Cayston® 75mg powder and solvent for nebuliser solution Available from, Cited. Feb 29 2012. http://www.medicines.org.uk/emc/medicine/22358/SPC/cayston%2075%20mg%20powder%20and%20solvent%20for%20nebuliser%20solution/.
9. Ramsey B.W., Pepe M.S., Quan J.M., Otto K.L., Montgomery A.B., Williams-Warren J, et al. Cystic fibrosis inhaled tobramycin study group. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Eng J Med 1999, 340:23-30.
10. Prescribing information: AZACTAM® (aztreonam) for injection, USP Available from, Cited 29 Feb 2012. http://packageinserts.bms.com/pi/pi_azactam.pdf.
11. McCoy K.S., Quittner A.L., Oermann C.M., Gibson R.L., Retsch-Bogart G.Z., Montgomery A.B. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med 2008, 178:921-928.
12. Retsch-Bogart G.Z., Quittner A.L., Gibson R.L., Oermann C.M., McCoy K.S., Montgomery A.B., et al. Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis. Chest 2009, 135:1223-1232.
13. Oermann C.M., Retsch-Bogart G.Z., Quittner A.L., Gibson R.L., McCoy K.S., Montgomery A.B., et al. An 18-month study, AIR-CF3, of the safety and improvement in pulmonary function and respiratory symptoms with repeated courses of aztreonam for inhalation solution in patients with cystic fibrosis and airway Pseudomonas aeruginosa. Pediatr Pulmonol 2010, 45:1121-1134.
14. Rosenfeld M., Emerson J., Williams-Warren J., Pepe M., Smith A., Montgomery A.B., et al. Defining a pulmonary exacerbation in cystic fibrosis. J Pediatr 2001, 139:359-365.
15. Quittner A.L., Buu A., Messer M.A., Modi A.C., Watrous M. Development and validation of the cystic fibrosis questionnaire in the United States: a health related quality of life measure for cystic fibrosis. Chest 2005, 128:2347-2354.
16. Atkinson M.J., Sinha A., Hass S.L., Colman S.S., Kumar R.N., Brod M., et al. Validation of a general measure of treatment satisfaction, the treatment satisfaction questionnaire for medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004, 2:12.
17. Siddiqui O., Hung H.M., O'Neill R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat 2009, 19:227-246.
18. Saiman L., Siegel J., the CF Foundation Consensus Conference on Infection Control Participants Infection control recommendations for patients with cystic fibrosis: microbiology, important pathogens, and infection control practices to prevent patient-to-patient transmission. Infect Control Hosp Epidemiol 2003, 24:S6-S52.
19. Clinical and Laboratory Standards Institute Performance standards for antimicrobial susceptibility testing; twentieth informational supplement 2010, CLSI, Wayne (PA).
20. Konstan M.W., Morgan W.J., Butler S.M., Pasta D.J., Craib M.L., Silva S.J., et al. Risk factors for rate of decline in forced expiratory volume in one second in children and adolescents with cystic fibrosis. J Pediatr 2007, 151:134-139.
21. 1 decline in both adults and children with cystic fibrosis. Pediatr Pulmonol 2011, 46:393-400.
22. Cystic Fibrosis Foundation.Patient Registry Annual data report to the center directors 2011.
23. Montgomery A.B., Lewis S., Higuchi K., Marshall B., Oermann C. Hospitalization risk of current standard of care (SOC) vs. aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) [abstract 806]. Am J Respir Crit Care Med 2009, 179:A1188.
24. Konstan M.W., Flume P.A., Kappler M., Chiron R., Higgins M., Brockhaus F., et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: the EAGER trial. J Cyst Fibros 2010, 10:54-61.