Systematic review of the dry powder inhalers colistimethate sodium and tobramycin in cystic fibrosis

European Respiratory Review

Volumn 22, Issue 130, 2013, Pages 476-486

  Uttley, Lesley ^a   Harnan, Sue ^a   Cantrell, Anna ^a   Taylor, Chris ^b   Walshaw, Martin ^c   Brownlee, Keith ^d   Tappenden, Paul ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b SHEFFIELD CHILDREN S HOSPITAL   (United Kingdom)

^c LIVERPOOL HEART AND CHEST HOSPITAL   (United Kingdom)

^d LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

COLISTIMETHATE; COLISTIN; TOBRAMYCIN; ANTIINFECTIVE AGENT; COLISTINMETHANESULFONIC ACID; POWDER;

ABNORMAL RESPIRATORY SOUND; ACUTE DISEASE; ADOLESCENT; ADULT; CHILD; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; COUGHING; CRACKLE; CYSTIC FIBROSIS; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG COST; DRUG EFFECT; DRUG FORMULATION; DRY POWDER INHALER; DYSGEUSIA; DYSPHONIA; DYSPNEA; FATIGUE; FEMALE; FEVER; FOLLOW UP; FORCED EXPIRATORY VOLUME; HEADACHE; HEMOPTYSIS; HUMAN; LUNG CONGESTION; LUNG DISEASE; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MEDICAL TECHNOLOGY; MORBIDITY; MULTICENTER STUDY; NAUSEA; NEBULIZATION; NONHUMAN; NOSE OBSTRUCTION; OPEN STUDY; OROPHARYNX PAIN; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHARYNGITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; REVIEW; RHINORRHEA; SCHOOL CHILD; SIDE EFFECT; SINUSITIS; SPUTUM EXAMINATION; SYSTEMATIC REVIEW; THORAX PAIN; THROAT IRRITATION; TREATMENT RESPONSE; UNITED KINGDOM; VOMITING; WHEEZING; ANALOGS AND DERIVATIVES; DISEASE COURSE; DRUG EFFECTS; EVIDENCE BASED MEDICINE; INHALATIONAL DRUG ADMINISTRATION; ISOLATION AND PURIFICATION; LUNG; METHODOLOGY; MICROBIOLOGY; PATHOPHYSIOLOGY; POWDER; PSEUDOMONAS INFECTIONS; TIME; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ANTI-BACTERIAL AGENTS; COLISTIN; CYSTIC FIBROSIS; DISEASE PROGRESSION; DRY POWDER INHALERS; EVIDENCE-BASED MEDICINE; FORCED EXPIRATORY VOLUME; HUMANS; LUNG; POWDERS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RESEARCH DESIGN; TIME FACTORS; TOBRAMYCIN; TREATMENT OUTCOME;

EID: 84888815046     PISSN: 09059180     EISSN: 16000617     Source Type: Journal    
DOI: 10.1183/09059180.00001513     Document Type: Review

References (24)

1. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Assessment Report: Colobreathe. EMEA/H/C/001225. 2011.
2. Cystic Fibrosis Trust. UKCF Registry Annual Data Report. Bromley, Cystic Fibrosis Trust, 2010.
3. Kosorok MR, Zeng L, West SH, et al. Acceleration of lung disease in children with cystic fibrosis after Pseudomonas aeruginosa acquisition. Pediatr Pulmonol 2001; 32: 277-287.
4. Cystic Fibrosis Trust. UKCF Registry Annual Data Report. Bromley, Cystic Fibrosis Trust, 2009.
5. Doring G. Prevention of Pseudomonas aeruginosa infection in cystic fibrosis patients. Int J Med Microbiol 2010; 300: 573-577.
6. Davies JC, Alton EW, Bush A. Cystic fibrosis. BMJ 2007; 335: 1255-1259.
7. Islam N, Gladki E. Dry powder inhalers (DPIs) - a review of device reliability and innovation. Int J Pharm 2008; 360: 1-11.
8. National Institute for Health and Clinical Excellence (NICE). Colistimethate sodium and tobramycin dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis. 2010. www.nice.org.uk/nicemedia/live/14134/63269/63269.pdf Date last updated: May 2013. Date last accessed: September 30, 2013.
9. Tappenden P, Harnan S, Uttley L, et al. Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis [ID342]. 2012. www.nice.org.uk/nicemedia/live/13068/61112/61112.pdf Date last updated: March 13, 2012. Date last accessed: September, 30: 2013.
10. European Medicines Committee. Committee for Medicinal Products for Human Use (CHMP). Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis. 2009. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12/WC500017055.pdf Date last updated: October 22, 2009. Date last accessed: September 30, 2013.
11. Centre for Reviews and Dissemination. Systematic Reviews. CRD's guidance for undertaking systematic reviews in health care. York, University of York, 2009.
12. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009; 6: e1000097.
13. Konstan MW, Flume PA, Kappler M, et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: the EAGER trial. J Cyst Fibros 2011; 10: 54-61.
14. Davies JC, Hall P, Francis J, et al. A dry powder formulation of colistimethate sodium is safe and well tolerated in adults and children with CF. Pediatr Pulmon 2004; 38: Suppl. 27, 283
15. Konstan M, Flume PA, Brockhaus G, et al. Safety and efficacy of tobramycin inhalation powder (TIP) in treating CF patients infected with Pseudomonas aeruginosa (Pa). J Cyst Fibros 2010; 9: Suppl. 1, S22.
16. Novartis Pharmaceuticals. Colistimethate sodium powder (Colobreathe1) and tobramycin powder for inhalation (TOBI Podhaler1) for the treatment of pseudomonas lung infection in cystic fibrosis - Novartis submission to NICE. Novartis submission to NICE 2011. www.nice.org.uk/nicemedia/live/13068/61134/61134.pdf Date last accessed: September 30, 2013.
17. Forest Laboratories UK Ltd. Colistimethate sodium powder for inhalation for the treatment of Pseudomonas lung infection in cystic fibrosis - Forest Submission to NICE. Forest Submission to NICE 2011. www.nice.org.uk/nicemedia/live/13068/61132/61132.pdf Date last accessed: September 30, 2013.
18. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment Report: TOBI Podhaler. EMEA/H/C/002155. London, ECDC, 2012.
19. Schuster A, Haliburn C, Döring G, et al. Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study. Thorax 2013; 68: 344-350.
20. Ramsey BW, 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: 23-30.
21. Hurley MN, Prayle AP, Smyth AR. Delayed publication of clinical trials in cystic fibrosis. J Cyst Fibros 2012; 11: 14-17.
22. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline: Clinical safety data management - definitions and standards for expedited reporting E2A. 1994. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf Date last updated: October 27, 1994. Date last accessed: September 30, 2013.
23. Terzano C, Taurino AE, Peona V. Nebulized tobramycin in patients with chronic respiratory infections during clinical evolution of Wegener's granulomatosis. Eur Rev Med Pharmacol Sci 2001; 5: 131-138.
24. Robinson CA, Kuhn RJ, Craigmyle J, et al. Susceptibility of Pseudomonas aeruginosa to cefepime versus ceftazidime in patients with cystic fibrosis. Pharmacotherapy 2001; 21: 1320-1324.