Ciprofloxacin DPI: A randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis

BMJ Open Respiratory Research

Volumn 2, Issue 1, 2015, Pages 1-10

  Dorkin, Henry L ^a   Staab, Doris ^b   Operschall, Elisabeth ^c   Alder, Jeff ^d   Criollo, Margarita ^e  

^a BOSTON CHILDREN S HOSPITAL   (United States)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c BAYER PHARMA AG   (Germany)

^d Bayer HealthCare Pharmaceuticals Inc   (United States)

^e Bayer Inc   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CIPROFLOXACIN; PLACEBO;

ADOLESCENT; ARTICLE; CHILD; CONTROLLED STUDY; CYSTIC FIBROSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HUMAN; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDOMONAS AERUGINOSA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL;

EID: 85019650776     PISSN: None     EISSN: 20524439     Source Type: Journal    
DOI: 10.1136/bmjresp-2015-000100     Document Type: Article

References (34)

1. Gibson RL, Burns JL, Ramsey BW. Pathophysiology and management of pulmonary infections in cystic fibrosis. Am J Respir Crit Care Med 2003;168:918-51.
2. Davis PB. Cystic fibrosis since 1938. Am J Respir Crit Care Med 2006;173:475-82.
3. Cystic Fibrosis Foundation 2011 Patient Registry Report. Cystic Fibrosis Foundation, 2011. http://www.cff.org/UploadedFiles/ research/ClinicalResearch/2011-Patient-Registry.pdf (accessed Mar 2015).
4. Flume PA, Robinson KA, O'Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care 2009;54:522-37.
5. Bendiak GN, Ratjen F. The approach to Pseudomonas aeruginosa in cystic fibrosis. Semin Respir Crit Care Med 2009;30:587-95.
6. Laube BL, Janssens HM, de Jongh FH, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J 2011;37:1308-31.
7. Heijerman H, Westerman E, Conway S, et al. Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: A European consensus. J Cyst Fibros 2009;8:295-15.
8. Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J 2009;18:243-9.
9. Geller DE, Konstan MW, Smith J, et al. Novel tobramycin inhalation powder in cystic fibrosis subjects: pharmacokinetics and safety. Pediatr Pulmonol 2007;42:307-13.
10. Parkins MD, Elborn JS. Tobramycin inhalation powder: a novel drug delivery system for treating chronic Pseudomonas aeruginosa infection in cystic fibrosis. Expert Rev Respir Med 2011;5: 609-22.
11. Geller DE, Flume PA, Griffith DC, et al. Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects. Antimicrob Agents Chemother 2011;55:2636-40.
12. Novartis Pharmaceuticals Corporation. TOBI® PODHALER™ (tobramycin inhalation powder) TOBI® PODHALER™ (tobramycin inhalation powder) prescribing information. 2013. http://www.pharma. us.novartis.com/product/pi/pdf/tobipodhaler.pdf
13. Stass H, Nagelschmitz J, Kappeler D, et al. Lung deposition of ciprofloxacin dry powder for inhalation in healthy subjects and patients suffering from chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis. Poster presentation at International Congress of the American Thoracic Society; Philadelphia, USA, 2013.
14. Gupta A, Tarara T, Miller D, et al. A novel high-payload dry powder formulation of ciprofloxacin for management of chronic lung infections. American Association of Pharmaceutical Scientists Annual Meeting; Washington, USA, 2011; Poster R6156.
15. Weers JG, Tarara TE. The PulmoSphere™ platform for pulmonary drug delivery. Ther Deliv 2014;5:277-95.
16. Stass H, Baumann-Noss S, Delesen H, et al. Pharmacokinetics of inhaled ciprofloxacin powder. 31st European Cystic Fibrosis Conference; Prague, Czech Republic, 2008; Poster P103.
17. Wilson R, Welte T, Polverino E, et al. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J 2013;41:1107-15.
18. Stass H, Nagelschmitz J, Willmann S, et al. Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: a phase I study. Clin Drug Investig 2013;33:419-27.
19. van Westreenen M, Tiddens HA. New antimicrobial strategies in cystic fibrosis. Paediatr Drugs 2010;12:343-52.
20. Bayer HealthCare Pharmaceuticals. CIPRO® (ciprofloxacin hydrochloride). 2009. http://www.univgraph.com/bayer/inserts/ ciprotab.pdf
21. Bayer Plc. (Ciprofloxacin) Ciproxin tablets 500 mg Summary of Product Characteristics. 2010. https://www.medicines.org.uk/emc/ medicine/20346/SPC/Ciproxin+Tablets+500mg/
22. Bayer Plc. (Ciprofloxacin) Ciproxin Infusion Summary of Product Characteristics. 2010. https://www.medicines.org.uk/emc/medicine/ 2536
23. Høiby N. Recent advances in the treatment of Pseudomonas aeruginosa infections in cystic fibrosis. BMC Med 2011;9:32.
24. Herrmann G, Yang L, Wu H, et al. Colistin-tobramycin combinations are superior to monotherapy concerning the killing of biofilm Pseudomonas aeruginosa. J Infect Dis 2010;202:1585-92.
25. Rao P, McCaughan J, McCalmont M, et al. Comparison of antibiotic susceptibility patterns in Pseudomonas aeruginosa isolated from adult patients with cystic fibrosis (CF) with invasive Pseudomonas aeruginosa from non-CF patients. J Cyst Fibros 2012;11:349-52.
26. Alothman GA, Ho B, Alsaadi MM, et al. Bronchial constriction and inhaled colistin in cystic fibrosis. Chest 2005;127:522-9.
27. Geller DE, Nasr SZ, Piggott S, et al. Tobramycin inhalation powder in cystic fibrosis patients: response by age group. Respir Care 2014;59:388-98.
28. Stass H, Weimann B, Nagelschmitz J, et al. Tolerability and pharmacokinetic properties of ciprofloxacin dry powder for inhalation in patients with cystic fibrosis: a phase I, randomized, dose-escalation study. Clin Ther 2013;35:1571-81.
29. Stass H, Delesen H, Nagelschmitz J, et al. Safety and pharmaockinetics of ciprofloxacin dry powder for inhalation in cystic fibrosis: a phase I, randomized, single-dose, dose-escalation study. J Aerosol Med Pulm Drug Deliv 2015;28:106-15.
30. Stass H, Nagelschmitz J, Kappeler D, et al. Lung deposition of Ciprofloxacin Dry Powder for Inhalation in healthy subjects and patients suffering from chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis (abstract). Am J Respir Crit Care Med 2013;187:A1507.
31. Van Devanter D, Konstan M. Cystic fibrosis drug development: victims of our own success. Proc Resp Drug Deliv 2008;1:11-7.
32. Stass H, Baumann-Noss S, Delesen H, et al. Ciprofloxacin PulmoSphere® inhalational powder: a healthy volunteer study. American Thoracic Society International Conference; Toronto, Canada, 2008; Poster G50.
33. 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.
34. LiPuma JJ. Microbiological and immunologic considerations with aerosolized drug delivery. Chest 2001;120:118S-23S.