Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis

Chest

Volumn 135, Issue 5, 2009, Pages 1223-1232

  Retsch Bogart, George Z ^a,h   Quittner, Alexandra L ^b   Gibson, Ronald L ^c   Oermann, Christopher M ^d   McCoy, Karen S ^e   Montgomery, A Bruce ^f   Cooper, Peter J ^g  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b UNIVERSITY OF MIAMI   (United States)

^c SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e OHIO STATE UNIVERSITY   (United States)

^f GILEAD SCIENCES INC   (United States)

^g CHILDREN S HOSPITAL AT WESTMEAD   (Australia)

^h UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

Aztreonam; Cystic fibrosis; Inhaled antibiotics; Patient reported outcomes; Pseudomonas; Respiratory symptoms

Indexed keywords

AMIKACIN; AZTREONAM; AZTREONAM PLUS LYSINE; CEFEPIME; CEFTAZIDIME; CIPROFLOXACIN; DORNASE ALFA; FLUTICASONE PROPIONATE; GENTAMICIN; LYSINE; MEROPENEM; PANCREAS ENZYME; PIPERACILLIN; PLACEBO; SALMETEROL XINAFOATE; TIMENTIN; TOBRAMYCIN; UNCLASSIFIED DRUG; VITAMIN;

ABDOMINAL PAIN; ACADEMIC ACHIEVEMENT; ADULT; AGED; ANAPHYLAXIS; ANTIBIOTIC SENSITIVITY; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYSTIC FIBROSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EATING; EMOTION; FATIGUE; FEMALE; FORCED EXPIRATORY VOLUME; HEALTH STATUS; HEMOPTYSIS; HUMAN; LARYNX PAIN; LUNG FUNCTION; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; NOSE CONGESTION; PATIENT COMPLIANCE; PATIENT MONITORING; PHYSICAL PERFORMANCE; PRIORITY JOURNAL; PSEUDOMONAS INFECTION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SELF REPORT; SIDE EFFECT; SORE THROAT; SPUTUM ANALYSIS; SYMPTOMATOLOGY; THORAX PAIN; THROAT IRRITATION; TREATMENT DURATION; TREATMENT OUTCOME; WHEEZING;

EID: 65949124667     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.08-1421     Document Type: Article

References (31)

1. Cystic Fibrosis Foundation Patient Registry. 2005 Annual data report to the center directors. Bethesda, MD: Cystic Fibrosis Foundation, 2006
2. Novartis. Prescribing information, TOBI: tobramycin inhalation solution, USP. Available at; http://www.pharma.us.novartis.com/product/pi/pdf/tobi.pdf. Accessed October 28, 2008
3. Genentech. Prescribing information, Pulmozyme: dornase alfa. Available at: http://www.gene.com/gene/products/information/opportunistic/pulmozyme/ insert.jsp. Accessed October 28, 2008
4. Clement A, Tamalet A, Leroux E, et al. Long term effects of azithromycin in patients with cystic fibrosis: a double blind, placebo controlled trial. Thorax 2006; 61:895-902
5. Gibson RL, Burns JL, Ramsey BW. State of the art: pathophysiology and management of pulmonary infections in cystic fibrosis. Am J Respir Crit Care Med 2003; 168:918-951 (Pubitemid 37267172)
6. Riekert KA, Mogayzel PJ, Bilderback A, et al. Medication adherence among children, adolescents, and adults with CF [abstract]. Pediatr Pulmonol 2007; 42:405 (abstract 563)
7. Gibson RL, Retsch-Bogart GZ, Oermann C, et al. Microbiology, safety and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatr Pulmonol 2006; 41:656-665
8. Bristol-Myers Squibb Company. Prescribing information, Azactam: aztreonam injection. Available at: http://www.fda.gov/cder/foi/label/2002/50632slr011lbl. pdf. Accessed October 28, 2008
9. Dietzsch HJ, Gottschalk B, Heyne K, et al. Cystic fibrosis: comparison of two mucolytic drugs for inhalation treatment (acetylcysteine and arginine hydrochloride). Pediatrics 1975; 55:96-100
10. McCoy KS, Quittner AL, Oermann CM, et al. Inhaled aztreonam lysine is effective in intensively-treated patients with cystic fibrosis. Am J Respir Crit Care Med 2008; 178:921-928
11. Flume PA, O'Sullivan BP, Robinson KA, et al. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med 2007; 176:957-969
12. Henry B, Aussage P, Grosskopf C, et al. Development of the Cystic Fibrosis Questionnaire (CFQ) for assessing quality of life in pediatric and adult patients. Qual Life Res 2003; 12:63-76
13. Quittner AL, Buu A, Messer MA, et al. 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
14. Modi AC, Quittner AL. Validation of a disease-specific measure of health-related quality of life for children with cystic fibrosis. J Pediatr Psychol 2003; 28:535-546
15. US Food and Drug Administration. Draft guidance on patient-reported outcome measures. Available at: http://www.fda.gov/cder/guidance/5460dft.htm. Accessed October 28, 2008
16. American Thoracic Society Committee on Diagnostic Standards for Non-Tuberculous Respiratory Diseases. Standardization of spirometry 1994 update. Am J Respir Crit Care Med 1995; 152:1107-1136
17. Knudson RJ, Lebowitz MD, Holberg CJ, et al. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis 1983; 127:725-734
18. Bucholski A, Keller M, Balcke A, et al. In vitro performance of eFlow, an electronic inhaler for administration of a novel aztreonam formulation to CF patients. Pediatr Pulmonol [abstract] 2003; 35(suppl):321 (abstract 392)
19. Guyatt GH. Making sense of quality-of-life data. Med Care 2000; 38(suppl):175-179
20. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10:407-415 (Pubitemid 20025670)
21. Quittner AL, McCoy K, Montgomery B. Inhaled antibiotics to treat stable patients with cystic fibrosis and Pseudomonas aeruginosa (PA): measuring patient perception of symptom improvement [abstract]. Pediatr Pulmonol 2007; 42:301 (abstract 280)
22. Burns JL, Emerson J, Stapp JR, et al. Microbiology of sputum from patients at cystic fibrosis centers in the United States. Clin Infect Dis 1998; 27:158-163
23. Elkins MR, Robinson M, Rose BR, et al. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med 2006; 354:229-240
24. Donaldson SH, Bennett WD, Zeman KL, et al. Mucus clearance and lung function in cystic fibrosis with hypertonic saline. N Engl J Med 2006; 354:241-250
25. Goss CH, Quittner AL. Patient-reported outcomes in cystic fibrosis. Proc Am Thorac Soc 2007; 4:378-386 (Pubitemid 47330875)
26. Modi AC, Lim CS, Yu N, et al. Multi-method measurement of treatment adherence for children with cystic fibrosis and its relationship to health-related quality of life [abstract]. Pediatr Pulmonol 2005; 40:371
27. Retsch-Bogart GZ, Burns JL, Otto KL, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatr Pulmonol 2008; 43:47-58
28. Ramsey BW, Pepe MS, Quan JM, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Engl J Med 1999; 340:23-30
29. Lamb HM, Goa KL. Drugs in disease management: management of patients with cystic fibrosis: defining the role of inhaled tobramycin. Dis Manage Health Outcomes 1999; 6:93-108
30. Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med 1994; 331:637-642
31. Oermann CM, McCoy KA, Retsch-Bogart GZ, et al. Effect of multiple Aztreonam Lysine for Inhalation (AZLI) cycles on disease-related endpoints and safety in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): interim analysis of 12 month data [abstract]. J Cystic Fib 2008; 7(suppl):S25 (abstract 100)