Inhaled, dual release liposomal ciprofloxacin in non-cystic fibrosis bronchiectasis (ORBIT-2): A randomised, double-blind, placebo-controlled trial

Thorax

Volumn 68, Issue 9, 2013, Pages 812-817

  Serisier, David J ^a   Bilton, Diana ^b   De Soyza, Anthony ^c   Thompson, Philip J ^d   Kolbe, John ^e   Greville, Hugh W ^f   Cipolla, David ^g   Bruinenberg, Paul ^h   Gonda, Igor ^g  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b ROYAL BROMPTON HOSPITAL   (United Kingdom)

^c NEWCASTLE UNIVERSITY   (United Kingdom)

^d UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^e UNIVERSITY OF AUCKLAND   (New Zealand)

^f ROYAL ADELAIDE HOSPITAL   (Australia)

^g ARADIGM CORPORATION   (United States)

^h Eagle Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CHOLINERGIC RECEPTOR BLOCKING AGENT; CIPROFLOXACIN; LIPOSOME; MACROLIDE; MANNITOL; PLACEBO; PREDNISONE;

ADOLESCENT; ANTIBIOTIC RESISTANCE; ARTICLE; AUSTRALIA; BACTERIAL CLEARANCE; BACTERIAL COUNT; BRONCHIECTASIS; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CYSTIC FIBROSIS; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LIPOSOMAL DELIVERY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEW ZEALAND; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SPUTUM CULTURE;

BRONCHIECTASIS; RESPIRATORY INFECTION;

ADMINISTRATION, INHALATION; AGED; ANTI-BACTERIAL AGENTS; BRONCHIECTASIS; CIPROFLOXACIN; DELAYED-ACTION PREPARATIONS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LIPOSOMES; MALE; MIDDLE AGED; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; SPUTUM; TIME FACTORS;

EID: 84881556337     PISSN: 00406376     EISSN: 14683296     Source Type: Journal    
DOI: 10.1136/thoraxjnl-2013-203207     Document Type: Article

References (23)

1. Wilson CB, Jones PW, O'Leary CJ, et al. Effect of sputum bacteriology on the quality of life of patients with bronchiectasis. Eur Respir J 1997;10:1754-60. (Pubitemid 27368366)
2. King PT, Holdsworth SR, Freezer NJ, et al. Microbiologic follow-up study in adult bronchiectasis. Respir Med 2007;101:1633-8. (Pubitemid 46930715)
3. Martinez-Garcia MA, Soler-Cataluna JJ, Perpina-Tordera M, et al. Factors associated with lung function decline in adult patients with stable non-cystic fibrosis bronchiectasis. Chest 2007;132:1565-72. (Pubitemid 350156014)
4. 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. (Pubitemid 29024680)
5. O'Donnell AE, Barker AF, Ilowite JS, et al. Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase 1. Chest 1998;113:1329-34. (Pubitemid 28223825)
6. Barker AF, Couch L, Fiel SB, et al. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med 2000;162:481-5. (Pubitemid 30647187)
7. Bilton D, Henig N, Morrissey B, et al. Addition of inhaled tobramycin to ciprofloxacin for acute exacerbations of Pseudomonas aeruginosa infection in adult bronchiectasis. Chest 2006;130:1503-10. (Pubitemid 44786746)
8. Scheinberg P, Shore E. A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest 2005;127:1420-26. (Pubitemid 46224309)
9. Drobnic ME, Sune P, Montoro JB, et al. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. Ann Pharmacother 2005;39:39-44. (Pubitemid 40052376)
10. Murray MP, Govan JRW, Doherty CJ, et al. A randomised controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med 2011;183:491-9.
11. Blanchard JD. Pulmonary drug delivery as a first response to bioterrorism. In: Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ. Respiratory drug delivery X. River Grove, IL: Davis Healthcare International, 2006:73-82.
12. Wong JP, Yang H, Blasetti KL, et al. Liposome delivery of ciprofloxacin against intracellular Francisca tularensis infection. J Control Release 2003;92:265-73. (Pubitemid 38366150)
13. Bruinenberg P, Serisier DJ, Cipolla D, et al. Safety, tolerability and pharmacokinetics of novel liposomal ciprofloxacin formulations for inhalation in healthy volunteers and non-cystic fibrosis bronchiectasis patients [abstract]. Am J Respir Crit Care Med 2010;181:A 3192.
14. Serisier DJ. Inhaled antibiotics for lower respiratory tract infections: focus on ciprofloxacin. Drugs Today 2012;48:339-51.
15. Pye A, Hill SL, Bharadwa P, et al. Effect of storage and postage on recovery and quantitation of bacteria in sputum samples. J Clin Pathol 2008;61:352-4. (Pubitemid 351354244)
16. 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;331:637-42. (Pubitemid 24276863)
17. Wilson R, Welte T, Polverino E, et al. Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J 2013;41:1107-15.
18. Geller DE, Flume PA, Staab D, et al. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. Am J Respir Crit Care Med 2011;183:1510-16.
19. Trapnell BC, McColley SA, Kissner DG, et al. Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with Pseudomonas airway infection. Am J Respir Crit Care Med 2012;185:171-8.
20. McCoy KS, Quittner AL, Oermann CM, et al. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med 2008;178:921-8.
21. Serisier DJ, Martin M, McGuckin M, 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: 1260-7.
22. 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;380:660-7.
23. Moss RB. Long-term benefits of inhaled tobramycin in adolescent patients with cystic fibrosis. Chest 2002;121:55-63. (Pubitemid 34114228)