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Review
. 2018 Mar 30;3(3):CD001021.
doi: 10.1002/14651858.CD001021.pub3.

Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis

Sherie Smith  1 , Nicola J Rowbotham, Kate H Regan
Affiliations
Review

Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis

Sherie Smith et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Inhaled antibiotics are commonly used to treat persistent airway infection with Pseudomonas aeruginosa that contributes to lung damage in people with cystic fibrosis. Current guidelines recommend inhaled tobramycin for individuals with cystic fibrosis and persistent Pseudomonas aeruginosa infection who are aged six years or older. The aim is to reduce bacterial load in the lungs so as to reduce inflammation and deterioration of lung function. This is an update of a previously published review.

Objectives: To evaluate the effects long-term inhaled antibiotic therapy in people with cystic fibrosis on clinical outcomes (lung function, frequency of exacerbations and nutrition), quality of life and adverse events (including drug sensitivity reactions and survival).

Search methods: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched ongoing trials registries.Date of last search: 13 February 2018.

Selection criteria: We selected trials if inhaled anti-pseudomonal antibiotic treatment was used for at least three months in people with cystic fibrosis, treatment allocation was randomised or quasi-randomised, and there was a control group (either placebo, no placebo or another inhaled antibiotic).

Data collection and analysis: Two authors independently selected trials, judged the risk of bias, extracted data from these trials and judged the quality of the evidence using the GRADE system.

Main results: The searches identified 333 citations to 98 trials; 18 trials (3042 participants aged between five and 56 years) met the inclusion criteria. Limited data were available for meta-analyses due to the variability of trial design and reporting of results. A total of 11 trials (1130 participants) compared an inhaled antibiotic to placebo or usual treatment for a duration between three and 33 months. Five trials (1255 participants) compared different antibiotics, two trials (585 participants) compared different regimens of tobramycin and one trial (90 participants) compared intermittent tobramycin with continuous tobramycin alternating with aztreonam. One of the trials (18 participants) compared to placebo and a different antibiotic and so fell into both groups. The most commonly studied antibiotic was tobramycin which was studied in 12 trials.We found limited evidence that inhaled antibiotics improved lung function (four of the 11 placebo-controlled trials, n = 814). Compared to placebo, inhaled antibiotics also reduced the frequency of exacerbations (three trials, n = 946), risk ratio 0.66 (95% confidence interval (CI) 0.47 to 0.93). There were insufficient data for us to be able to report an effect on nutritional outcomes or survival and there were insufficient data for us to ascertain the effect on quality of life. There was no significant effect on antibiotic resistance seen in the two trials that were included in meta-analyses. Tinnitus and voice alteration were the only adverse events significantly more common in the inhaled antibiotics group. The overall quality of evidence was deemed to be low for most outcomes due to risk of bias within the trials and imprecision due to low event rates.Of the eight trials that compared different inhaled antibiotics or different antibiotic regimens, there was only one trial in each comparison. Forced expiratory volume at one second (FEV1) % predicted was only found to be significantly improved with aztreonam lysine for inhalation compared to tobramycin (n = 273), mean difference -3.40% (95% CI -6.63 to -0.17). However, the method of defining the endpoint was different to the remaining trials and the participants were exposed to tobramycin for a long period making interpretation of the results problematic. No significant differences were found in the remaining comparisons with regard to lung function. Pulmonary exacerbations were measured in different ways, but one trial (n = 273) found that the number of people treated with antibiotics was lower in those receiving aztreonam than tobramycin, risk ratio 0.66 (95% CI 0.51 to 0.86). We found the quality of evidence for these comparisons to be directly related to the risk of bias within the individual trials and varied from low to high.

Authors' conclusions: Inhaled anti-pseudomonal antibiotic treatment probably improves lung function and reduces exacerbation rate, but pooled estimates of the level of benefit were very limited. The best evidence is for inhaled tobramycin. More evidence from trials measuring similar outcomes in the same way is needed to determine a better measure of benefit. Longer-term trials are needed to look at the effect of inhaled antibiotics on quality of life, survival and nutritional outcomes.

PubMed Disclaimer

Conflict of interest statement

Nicola Rowbotham: received non‐financial supprot (travel and accomodation) for conference attendance from TEVA. Remaining authors: none known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
4
4
Forest plot of comparison: 1 Inhaled anti‐pseudomonal antibiotic versus placebo, outcome: 1.6 Mean change in FVC (% predicted).
See this image and copyright information in PMC

References

References to studies included in this review

Assael 2013 {published data only}
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Flume 2016b {published data only}
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Kun 1984 {published data only}
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MacLusky 1989 {published data only}
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Murphy 2004 {published data only}
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Nathanson 1985 {published data only}
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Nikolaizik 2008 {published data only}
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Ramsey 1999 {published data only}
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Schuster 2013 {published data only}
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References to studies excluded from this review

Al‐Aloul 2004 {published data only}
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Alothman 2000 {published data only}
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Davies 2004 {published data only}
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Dodd 1998 {published data only}
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    1. Dorkin H, Criollo M, Reimnitz P, Alder J, Hampel B. Randomized, double‐blind, placebo‐controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared with placebo in patients with cystic fibrosis‐ a phase IIB study of ciprofloxacin dry powder for inhalation (DPI). Pediatric Pulmonology 2011;46 Suppl 34:296. [Abstract no: 235; CFGD Register: PI261; CFGD Register: PI261a; ]
    1. Dorkin HL, Staab D, Operschall E, Alder J, Criollo M. Ciprofloxacin DPI: a randomised, placebo‐controlled, phase IIb efficacy and safety study on cystic fibrosis. BMJ Open Respiratory Research 2015;2(1):e000100. [CFGD Register: PI261d; CRS: 5500135000001728; PUBMED: 26688732] - PMC - PubMed
    1. NCT00645788. Study to evaluate the safety and efficacy of ciprofloxacin (inhaled) in patients with cystic fibrosis [Randomized, double‐blind, placebo‐controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis]. https://clinicaltrials.gov/ct2/show/NCT00645788 28 March 2008. [CFGD Register: PI261b; ClinicalTrials.gov identifier: NCT00645788]
Dupont 2008 {published data only}
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818‐25. [CENTRAL: 876398; CFGD Register: PI207e // PI222c; CRS: 5500050000000084; PUBMED: 23749840] - PMC - PubMed
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818‐25. Online supplementary data. [CFGD Register: PI222d // PI207f ; CRS: 5500135000000003] - PMC - PubMed
    1. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo‐controlled studies of nebulized liposomal amikacin for inhalation (ArikaceTM) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [Abstract no: 227; CFGD Register: PI207d // PI255; ]
    1. Dupont L, Minic P, Fustic S, Mazurek H, Solyom E, Feketova A, et al. A randomised placebo‐controlled study of nebulized liposomal amikacin (Arikace™) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [Abstract no: 102; CFGD Register: PI207a]
    1. Dupont LJ, Clancy JP, Minic P, Goss CH, Fustic S, Mazurek Hetal. Evaluation of two phase II blinded and placebo‐controlled studies of nebulized liposomal amikacin (Arikace") in the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts). [Abstract no: A1836; CENTRAL: 758757; CFGD Register: PI222e // PI207g ; CRS: 5500050000000487]
Eisenberg 1997 {published data only}
    1. Eisenberg J, Pepe M, Williams‐Warren J, Vasiliev M, Montgomery AB, Smith AL, et al. A comparison of peak sputum tobramycin concentration in patients with cystic fibrosis using jet and ultrasonic nebulizer systems. Chest 1997;111:955‐62. [CFGD Register: PI117] - PubMed
Flume 2016a {published data only}
    1. Flume P, Devanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI283c // PI240f // PI284c ; CRS: 5500135000001302]
    1. Flume PA, Devanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi‐center, multinational, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT‐1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495‐502. [CFGD Register: PI284d; CRS: 5500135000001727; PUBMED: 26852040] - PubMed
    1. Flume PA, Devanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi‐center, multinational, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT‐1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495‐502. Online supplement. [CFGD Register: PI284e; CRS: 5500135000001734] - PubMed
    1. NCT01180634. MP‐376 (Aeroquin™, levofloxacin for inhalation) in patients with cystic fibrosis [A phase 3, multi‐center, multinational, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of MP‐376 (Levofloxacin Inhalation Solution; Aeroquin™) in stable cystic fibrosis patients]. clinicaltrials.gov/show/NCT01180634 12 August 2010. [CENTRAL: 1012532; CFGD Register: PI284a; CRS: 5500131000000190]
    1. Devanter D, Flume PA, Fleming R, Elborn J. How often is pulmonary exacerbation defined by ≥4 Fuchs criteria associated with antibiotic treatment?. Pediatric Pulmonology 2014;49 Suppl 38:356. [Abstract no: 388; CENTRAL: 1012531; CFGD Register: PI283b // PI284b ; CRS: 5500131000000188]
Franz 1985 {published data only}
    1. Franz MN, Spohn WA, Ronald PM. Evaluation of tobramycin aerosol therapy in cystic fibrosis. Cystic Fibrosis Club Abstracts; 1985. 1985; Vol. 26:143.
Frederiksen 1997 {published data only}
    1. Frederiksen B, Hansen A, Koch C, Hoiby N. Delay of recurrence of Pseudomonas aeruginosa in patients with cystic fibrosis with inhaled colistin and oral ciprofloxacin; a comparison between 3 weeks and 3 months of treatment. Pediatric Pulmonology 1997;Supp 14:288. [CFGD Register: PI118a]
    1. Frederiksen B, Pressler T, Koch C, Hoiby N. Endpoints for evaluating early anti‐pseudomonal treatment: changes in pseudomonas prevalence and in pulmonary function. Pediatric Pulmonology 2003;Suppl 25:334. [CFGD Register: PI118b]
Galeva 2011 {published data only}
    1. Galeva I, Higgins M, Piggott S, Angyalosi G. A randomized, double‐blind, placebo‐controlled study of tobramycin inhalation powder in patients with cystic fibrosis: the edit trial. Pediatric Pulmonology 2011;46 Suppl 34:344. [Abstract no: 366; CFGD Register: PI260a; ]
    1. Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, et al. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Current Medical Research and Opinion 2013;29(8):947‐56. [CFGD Register: PI260e] - PMC - PubMed
    1. Galeva I, Konstan MW, Higgins M, Piggott S, Angyalosi G, Brockhaus F, et al. A challenging double‐blind, placebo‐controlled study of tobramycin inhalation powder in cystic fibrosis: results of the EDIT trial. Journal of Cystic Fibrosis 2012;11 Suppl 1:S12. [Abstract no: WS5.6; CFGD Register: PI260b ; ]
    1. Konstan M, Flume P, Wan R, Perrin M, Maykut R, Angyalosi G. Long‐term safety and efficacy of tobramycin inhalation powder in cystic fibrosis patients with P. aeruginosa: the EDIT trials and its two open‐label extension studies. Pediatric Pulmonology 2013;48 Suppl 36:344. [Abstract no: 381; CFGD Register: PI260d]
    1. Konstan MW, Flume PA, Galeva I, Wan R, Debonnett LM, Maykut RJ, et al. One‐year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis. Pediatric Pulmonology 2016;51(4):372‐8. [CENTRAL: 1260415; CFGD Register: PI260g; CRS: 5500135000001730; PUBMED: 26709158] - PubMed
Geborek 2003 {published data only}
    1. Geborek A, Hjelte L, Lindblad A, Mared L, Eriksson L, Johannesson M, et al. Cross‐over study of TOBI® vs. intravenous tobramycin in combination treatment of pulmonary exacerbations in cystic fibrosis patients. Journal of Cystic Fibrosis 2003;Suppl 1:S22. [CFGD Register: PI176]
Geller 2004 {published data only}
    1. Geller DE, Rodriguez CA, Howenstine M, Murphy T, Voter K, Nickerson B, et al. The effects of doubling concentration of tobramycin solution for inhalation on pharmacokinetics (PK), safety and delivery time in patients with cystic fibrosis (CF). American Journal of Respiratory and Critical Care Medicine 2004;169(7). [Abstract no: A391; CFGD Register: PI183a]
    1. Rosenfeld M, Geller DE, Rodriguez CA, Howenstine M, Konstan M, Ordonez C, et al. Serum pharmacokinetics of two preparations of tobramycin solution for inhalation in young cystic fibrosis patients. American Journal of Respiratory and Critical Care Medicine 2004;169(7). [Abstract no: A386; CFGD Register: PI183b]
Geller 2007 {published data only}
    1. Geller DE, Howenstine M, Conrad C, Smith J, Mulye S, Shrewsbury SB. A phase 1 study to assess the tolerability of a novel tobramycin powder for inhalation (TPI) formulation in cystic fibrosis subjects. Pediatric Pulmonology 2004;38 Suppl 27:250. [CFGD Register: PI187a]
    1. Geller DE, Konstan MW, Smith J, Noonberg SB, Conrad C. Novel tobramycin inhalation powder in cystic fibrosis subjects: pharmacokinetics and safety. Pediatric Pulmonology 2007;42(4):307‐13. [CFGD Register: PI187c] - PubMed
    1. Rodriguez CA, Shrewsbury SB, Potter SN, Nardella P, Geller DE. Single dose pharmacokinetics of tobramycin after administration of a novel dry powder formulation (TPI) in subjects with cystic fibrosis (CF). Pediatric Pulmonology 2004;38 Suppl 27:250. [CFGD Register: PI187b]
Geller 2011a {published data only}
    1. Geller DE, Flume PA, Griffith DC, Morgan E, White D, Loutit J, et al. Pharmacokinetics (PK) of aerosol MP‐376 (Aeroquin; levofloxacin inhalation solution) in CF patients. Journal of Cystis Fibrosis 2010;9 Suppl 1:S23. [Abstract no: 87; CFGD Register: PI254a; ]
    1. Geller DE, Flume PA, Griffith DC, Morgan E, White D, Loutit JS, et al. Pharmacokinetics and safety of MP‐376 (levofloxacin inhalation solution) in cystic fibrosis subjects. Antimicrobial Agents and Chemotherapy 2011;55(6):2636‐40. [CFGD Register: PI254b; ] - PMC - PubMed
Geller 2011b {published data only}
    1. Conrad D, Flume P, Sindel L, Andrews S, Morgan L, Loutit J, et al. Phase 2b study of inhaled MP‐376 (Aeroquin, levofloxacin inhalation solution) in stable cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (PA) lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts). [CENTRAL: 1031676; CFGD Register: PI240g; CRS: 5500050000000360; EMBASE: 70839804]
    1. Flume P, Geller DE, Sindel L, Staab D, Fischer R, Riethmuller J, et al. Effects of inhaled MP‐376 (Aeroquin, levofloxacin inhalation solution) on lung function in stable cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (PA) lung function. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [Abstract no: 86; CFGD Register: PI240a]
    1. Flume P, Devanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c ; CRS: 5500135000001302]
    1. Flume PA, Geller DE, Loutit JS, Dudley MN, Conrad D, Mpex 204 Study Group. Effects of inhaled MP‐376 (AeroquinTM, levofloxacin inhalation solution) on cystic fibrosis patients with both Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA) lung infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S22. [Abstract no: 87; CFGD Register: PI240b]
    1. Geller D, Flume PA, Sindel L, Staab D, Fischer R, Loutit J, et al. Effects of inhaled MP‐376 (Aeroquin, levofloxacin inhalation solution) on the need for other anti‐pseudomonal antimicrobials in stable CF patients with chronic Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:301. [Abstract no: 232; CFGD Register: PI240c]
Gibson 2003 {published data only}
    1. Gibson RL, Emerson J, McNamara S. A randomized controlled trial of inhaled tobramycin in young children with cystic fibrosis: eradication of Pseudomonas from the lower airway. Pediatric Pulmonology 2002;Suppl 24:300. [CFGD Register: PI151c]
    1. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al. Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841‐9. [CFGD Register: PI151d] - PubMed
    1. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al. Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841. Online supplement. [CFGD Register: PI151e] - PubMed
    1. Rosenfeld M. Serum and lower respiratory tract tobramycin concentrations produced by inhaled tobramycin (TOBI) in young children with cystic fibrosis. Pediatric Pulmonology 1999;Suppl 19:106‐108. [CFGD Register: PI151b]
    1. Rosenfeld M, Borowitz D, Emerson J, Gibson R, McCoy K, McNamara S, et al. Serum pharmacokinetics and safety of inhaled tobramycin in very young CF patients. Pediatric Pulmonology 1999;Suppl 19:262. [CFGD Register: PI151s]
Gibson 2006 {published data only}
    1. Gibson RL, Retsch‐Bogart G, Ahrens R, Clancy J, Daines C, Milla C, et al. Safety and tolerability of aztreonam for inhalation (AI) in cystic fibrosis patients. Pediatric Pulmonology 2004;38 Suppl 27:253. [CFGD Register: PI188a]
    1. Gibson RL, Retsch‐Bogart GZ, Oermann C, Milla C, Pilewski J, Daines C, et al. Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatric Pulmonology 2006;41(7):656‐65. [CFGD Register: PI188b] - PubMed
Goss 2009 {published data only}
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818‐25. [CFGD Register: PI222c // PI207e] - PMC - PubMed
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with pseudomonas aeruginosa infection. Thorax 2013;68(9):818‐25. Online supplementary data. [CFGD Register: PI222d // PI207f ; CRS: 5500135000000003] - PMC - PubMed
    1. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo‐controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [Abstract no: 227; CFGD Register: PI222b // PI207d; ]
    1. Dupont LJ, Clancy JP, Minic P, Goss CH, Fustic S, Mazurek Hetal. Evaluation of two phase II blinded and placebo‐controlled studies of nebulized liposomal amikacin (Arikace") in the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts). [Abstract no: A1836; CENTRAL: 758757; CFGD Register: PI222e // PI207g ; CRS: 5500050000000487]
    1. Goss CH, Clancy JP, Nick JA, Billings J, Rubenstein RC, Young KR, et al. A phase 2 blinded and placebo‐controlled study of nebulized liposomal amikacin (Arikace™) in the treatment of CF patients with pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2009;44 Suppl 32:295. [Abstract no: 239; CFGD Register: PI222a]
Griffith 2008 {published data only}
    1. Geller DE, Flume P, Schwab R, Fornos P, Conrad DJ, Morgan E, et al. A phase 1 safety, tolerability and pharmacokinetic (PK) study of MP‐376 (levofloxacin solution for inhalation) in stable cystic fibrosis (CF) patients. Pediatric Pulmonology 2008;43 Suppl 31:315. [Abstract no: 321; CFGD Register: PI210b]
    1. Griffith DC, Hansen C, Pressler T, Balchen T, Jensen TJ, Geller DE, et al. Single‐dose pharmacokinetics of aerosol MP‐376 (levofloxacin solution for inhalation) in cystic fibrosis patients: PK‐PD implications. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CFGD Register: PI210a]
    1. Kearns GL, Rubino CM, Griffith DC, Geller DE, Forrest A, Bhavnani SM, et al. Levofloxacin pharmacokinetics (PK) after administration of MP‐376 (levofloxacin inhalation solution; Aeroquin) in children with cystic fibrosis. Journal of Cystic Fibrosis 2011;10 Suppl 1:S23. [Abstract no: 88; CFGD Register: PI210d]
    1. Stockmann C, Hillyard B, Ampofo K, Spigarelli MG, Sherwin CM. Levofloxacin inhalation solution for the treatment of chronic Pseudomonasaeruginosa infection among patients with cystic fibrosis. Expert Review of Respiratory Medicine 2015;9(1):13‐22. [CFGD Register: PI210c] - PubMed
Gulliver 2003 {published data only}
    1. Gulliver T, Wilson S, Williams G, Harris M, Cooper D. Nebulized tobramycin (intravenous solution) is tolerated without inducing cough and wheeze in cystic fibrosis patients. Thoracic Society of Australia & New Zealand Annual Scientific Meeting; 2003 April 4‐9; Adelaide, Australia. 2003. [Abstract no: P139; CFGD Register: PI184]
Hodson 2002 {published and unpublished data}
    1. Govan JR. Insights into cystic fibrosis microbiology from the European tobramycin trial in cystic fibrosis. Journal of Cystic Fibrosis 2002;1 Suppl 2:203‐8. [CFGD Register: PI153e] - PubMed
    1. Hodson ME, Gallagher CG. New clinical evidence from the European tobramycin trial in cystic fibrosis. Journal of Cystic Fibrosis 2002;1 Suppl 2:S199‐S202. [CFGD Register: PI153d] - PubMed
    1. Hodson ME, Gallagher CG, Govan JRW. A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis. European Respiratory Journal 2002;20(3):658‐64. [CFGD Register: PI153c] - PubMed
    1. Hodson ME, Gallagher CG, Govan JRW, PL TNDS 101 Clinical Trial Group. Randomised UK / Eire clinical trial of the efficacy and safety of tobramycin 300 mg/5 ml nebuliser solution or nebulised colistin in CF patients. Pediatric Pulmonology 2000;Suppl 20:248‐9. [CFGD Register: PI145b]
    1. Hodson ME, Gallagher CG, Govan JRW, the PL‐TNDS‐101 Clinical Trial Group. Randomised UK/Eire clinical trial of the efficacy and safety of tobramycin 300 mg/5 mL nebuliser solution or nebulised colistin. 13th International Cystic Fibrosis Congress; 2000 Jun 4‐8; Stockholm. 2000:145. [CFGD Register: PI145a]
Jenkins 1985 {published data only}
    1. Jenkins SG, Kelly WC, Mason WG, Peele JD, Cruse MA, Coludro EO, et al. Aerosolized amikacin administration to cystic fibrosis patients chronically infected with Pseudomonas aeruginosa. Cystic Fibrosis Club Abstracts; 1985. 1985; Vol. 28:147. [CFGD Register: PI131]
Knowles 1988 {published data only}
    1. Knowles NE, Hallberg TK, Colombe JL. Efficacy of aerosolized antibiotics combined with intravenous treatment of cystic fibrosis pulmonary exacerbation. Pediatric Pulmonology 1998;Suppl 2(1):120. [CFGD Register: PI87]
Konstan 2010a {published data only}
    1. Konstan MW, Geller DE, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder is effective and safe in the treatment of chronic pulmonary Pseudomonas aeruginosa (Pa) infection in patients with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2009;179. [Abstract no: A1186; CFGD Register: PI227a]
    1. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Effective treatment of chronic Pseudomonas aeruginosa (Pa) infection with tobramycin inhalation powder in CF patients. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27. [Abstract no: 105; CFGD Register: PI227b]
    1. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: The EVOLVE trial. Pediatric Pulmonology 2010;46:230‐8. [CFGD Register: PI227e; ] - PMC - PubMed
    1. McColley S, Rietschel E, Brockhaus F, Angyalosi G, Higgins M. Safety of inhaled tobramycin in patients with cystic fibrosis. Pediatric Pulmonology 2011;46 Suppl 34:344. [Abstract no: 365; CFGD Register: PI239h // PI227d ; ]
    1. NCT00125346. Tobramycin inhalation powder (TIP) in cystic fibrosis subjects (EVOLVE) [A randomized, double‐blind, placebo‐controlled, multicenter, phase 3 trial to assess the efficacy and safety of tobramycin inhalation powder (TIP) in cystic fibrosis (CF) subjects]. clinicaltrials.gov/ct2/show/NCT00125346 01 August 2005. [CFGD Register: PI227c]
Ledson 2002 {published data only}
    1. Ledson MJ, Gallagher MJ, Cowperthwaite C, Robinson M, Convery RP, Walshaw MJ. A randomised double blind placebo controlled crossover trial of nebulised taurolidine in adult CF patients colonised with B cepacia. 22nd European CF Conference; 1998 June 13‐19; Berlin, Germany. 1998:120. [CFGD Register: PI128a]
    1. Ledson MJ, Gallagher MJ, Robinson M, Cowperthwaite C, Willets T, Hart CA, Walshaw MJ. A randomized double‐blinded placebo‐controlled crossover trial of nebulized taurolidine in adult cystic fibrosis patients infected with Burkholderia cepacia. Journal of Aerosol Medicine 2002;15(1):51‐7. [CFGD Register: PI128b] - PubMed
Lenoir 2007 {published data only}
    1. Lenoir G, Antypkin YG, Miano A, Moretti P, Zanda M, Varoli G, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Paediatric Drugs 2007;9 Suppl 1:11‐20. [CFGD Register: PI196c] - PubMed
    1. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Aerosolized tobramycin in the treatment of patients with cystic fibrosis and pseudomonas aeruginosa infection. Journal of Cystic Fibrosis 2006;5 Suppl:S42. [CFGD Register: PI196b]
    1. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Highly concentrated aerosolized tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection. European Respiratory Journal 2005;26 Suppl 49:620s. [CFGD Register: PI196a]
Mainz 2014 {published data only}
    1. Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn‐Neise P, Koitschev A, et al. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double‐blind, placebo‐controlled pilot study. Drug Design, Development and Therapy 2014;8:209‐17. [CFGD Register: PI248b] - PMC - PubMed
    1. Mainz JG, Schien C, Schadlich K, Pfister W, Schelhorn‐Neise P, Koitschev A, et al. Sinonasal inhalation of tobramycin in cystic fibrosis patients with P. aeruginosa colonization of the upper airways ‐ results of a multicentric placebo‐controlled pilot study. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [Abstract no: 83; CFGD Register: PI248a]
    1. Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmüller J, Koitschev A, et al. Sinonasal inhalation of dornase alfa in CF: A double‐blind placebo‐controlled cross‐over pilot trial. Auris, Nasus, Larynx 2011;38(2):220‐7. [CENTRAL: 781345; CFGD Register: PI248c; CRS: 5500050000000201; PUBMED: 21030168] - PubMed
Mazurek 2014 {published data only}
    1. Cicirello H, Mazurek H, Chiron R, Pelikan L, Geidel C, Bolbas K, et al. Efficacy and safety of two inhaled tobramycin solutions in patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection: results from a head to head comparison. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A3121. [CENTRAL: 1031434; CFGD Register: PI249e; CRS: 5500050000000530; EMBASE: 70850327]
    1. Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, et al. Long‐term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatric Pulmonology 2014;49(11):1076‐89. [CENTRAL: 1015252; CFGD Register: PI249d; CRS: 5500131000000251; JID:: 8510590; PUBMED: 24464974] - PubMed
    1. Mazurek H, Chiron R, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al. Comparison of two inhaled tobramycin solutions in cystic fibrosis patients with chronic pseudomonas aeruginosa infection: results in different age subgroups. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28. [Abstract no: 111; CFGD Register: PI249b; ]
    1. Mazurek H, Chiron R, Varoli G, Santoro D, Cicirello H, Antipkin Y. Efficacy on lung function and safety of multiple courses of tobramycin 300mg/4 ml nebuliser solution (Bramitob) in patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection: results from a 48‐week extension phase. Journal of Cystic Fibrosis 2012;11 Suppl 1:S74. [Abstract no: 69; CFGD Register: PI249c; ]
    1. Mazurek H, Lenoir G, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al. Head‐to‐head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (Pa) infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28. [Abstract no: 110; CFGD Register: PI249a ; ]
McCoy 2008 {published data only}
    1. McCoy K, Retsch‐Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Investigation of susceptibility breakpoints for inhaled antibiotic therapies in cystic fibrosis. Pediatric Pulmonology 2010;45 Suppl 33:341. [Abstract no: 340; CFGD Register: PI212g/PI213i; ]
    1. McCoy K, Retsch‐Bogart G, Oermann C, Gibson R, Montgomery AB. Aztreonam lysine for inhalation (AZLI) for CF patients with P. aeruginosa (PA) infection. Journal of Cystic Fibrosis 2007;6 Suppl 1:S10. [CFGD Register: PI212a]
    1. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch‐Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American Journal of Respiratory Critical Care Medicine 2008;178(9):921‐8. [CFGD Register: PI212c] - PMC - PubMed
    1. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch‐Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2008;178(9):921‐8, Online data supplement. [CFGD Register: PI212d] - PMC - PubMed
    1. McCoy KS, Retsch‐Boagrt GZ, Gibson RL, Oermann CM, McKevitt M, Montgomery AB. Efficacy of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis and drug resistant P. aeruginosa (DRPA). Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 108; CFGD Register: PI212e // PI 213e]
Mullinger 2005 {published data only}
    1. Mullinger B, Brand P, Fischer A, Haubermann S, Scheuch G, Seitz J, et al. Intra‐pulmonal deposition of two different tobramycin formulations. Journal of Cystic Fibrosis 2005;4 Suppl 1:S53.
Nasr 2004 {published data only}
    1. Nasr SZ, Gordon D, Sakmar E, Eckhardt BP, Strouse PJ. Comparison of high resolution computerized tomography (HRCT) of the chest and pulmonary function testing in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis (CF) patients. European Respiratory Journal 2004;24 Suppl 48:P2403. [CFGD Register: DG2a]
    1. Nasr SZ, Gordon D, Sakmar E, Yu X, Christodoulou E, Eckhardt BP, et al. High resolution computerized tomography of the chest and pulmonary function testing in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis patients. Pediatric Pulmonology 2006;41(12):1129‐37. [CFGD Register: DG2c] - PubMed
    1. Nasr SZ, Gordon D, Yu X, Sakmar E, Eckhardt BP, Strause P. Comparison of high resolution computerized tomography (HRCT) of the chest and pulmonary function testing in evaluating of the effect of tobramycin solution for inhalation (TSI) in cystic fibrosis (CF) subjects with mild lung disease. Pediatric Pulmonology 2004;38 Suppl 27:299. [CFGD Register: DG2b]
    1. Nasr SZ, Sakmar E, Christodoulou E, Eckhardt BP, Streetman DS, Strouse PJ. The use of high resolution computerized tomography (HRCT) of the chest in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis lung disease. Pediatric Pulmonology 2010;45(5):440‐9. [CFGD Register: DG2e] - PubMed
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Nikolaizik 1996 {published data only}
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Oermann 2009 {published data only}
    1. Oermann CM, McCoy KS, Retsch‐Bogart GZ, Gibson R, McKevitt M, Montgomery B. Antibiotic susceptibility in Pseudomonas aeruginosa (PA) isolates following repeated exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis. Pediatric Pulmonology 2009;44 Suppl 32:309. [Abstract no: 278]
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    1. Oermann CM, McCoy KS, Retsch‐Bogart GZ, Gibson RL, Montgomery AB. Effect of multiple courses of aztreonam lysine for inhalation (AZLI) on FEV1 and weight in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): analysis of 18 month data from CP‐AI‐006. Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 107]
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Poli 2005 {published data only}
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Pradal 2002 {published data only}
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Proesmans 2008 {published data only}
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Ramsey 2005 {published data only}
    1. Anstead M, Heltshe SL, Khan U, Barbieri JT, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology and risk for re‐isolation in the EPIC trial. Journal of Cystic Fibrosis 2013;12(2):147‐53. [CENTRAL: 1089772; CFGD Register: PI202m; CRS: 5500135000000084; PUBMED: 22944725] - PMC - PubMed
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Ratjen 2006 {published data only}
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Retsch‐Bogart 2007 {published data only}
    1. McCoy K, Retsch‐Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Investigation of susceptibility breakpoints for inhaled antibiotic therapies in cystic fibrosis. Pediatric Pulmonology 2010;45 Suppl 33:341. [Abstract no: 340; CFGD Register: PI212g/PI213i; ]
    1. McCoy KS, Retsch‐Boagrt GZ, Gibson RL, Oermann CM, McKevitt M, Montgomery AB. Efficacy of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis and drug resistant P. aeruginosa (DRPA). Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 108; CFGD Register: PI213e // PI212e]
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Retsch‐Bogart 2008 {published data only}
    1. Burns JL, Stapp J, Lofland D, AI Phase 2 Study Group. Microbiology results from a phase 2 clinical study of aztreonam lysinate for inhalation (AI): a new inhaled antibiotic to treat CF patients with Pseudomonas aeruginosa (PA). Journal of Cystic Fibrosis 2005;4 Suppl:S55. [CFGD Register: PI211a]
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Rietschel 2009 {published data only}
    1. Rietschel E, Posselt HG, Heuer HE, Merkel N, Staab D. Pharmacokinetics of tobramycin (TOBI™) after 4 and 8 weeks of continuous once daily or twice daily inhalation. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27. [Abstract no: 106; CFGD Register: PI232a]
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Rosenfeld 2006 {published data only}
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Ruddy 2013 {published data only}
    1. Ruddy J, Emerson J, Moss R, Genatossio A, McNamara S, Burns JL, et al. Sputum tobramycin concentrations in cystic fibrosis patients with repeated administration of inhaled tobramycin. Journal of Aerosol Medicine and Pulmonary Drug Delivery 2013;26(2):69‐75. [CFGD Register: PI277] - PMC - PubMed
Sands 2014 {published data only}
    1. Sands D, Sapiejka E, Gaszczyk G, Mazurek H, for the T100 Study Group. Comparison of two tobramycin nebuliser solutions: pharmacokinetic, efficacy and safety profiles of T100 and TNS. Journal of Cystic Fibrosis 2014;13:653‐60. [CFGD Register: PI263c] - PubMed
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Schaad 1987 {published data only}
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Schaad 1997 {published data only}
    1. Schaad UB, Wedgwood J, Reuderberg A, Kraemer R, Hampel B. Ciprofloxacin as antipseudomonal treatment in patients with cystic fibrosis. Pediatric Infectious Disease Journal 1997;16(1):106‐11. [CFGD Register: PI116; CFGD Register: PI116; ] - PubMed
Shatunov 2001 {published data only}
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Smith 1989 {published data only}
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Stass 2009 {published data only}
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Stass 2014 {published data only}
    1. Stass H, Delesen H, Nagelschmitz J, Staab D. Safety and pharmacokinetics of ciprofloxacin dry powder for inhalation in cystic fibrosis: a phase I, randomized, single‐dose, dose‐escalation study. Journal of Aerosol Medicine and Pulmonary Drug Delivery 2015;28(2):106‐15. [CFGD Register: PI215c; DOI: 10.1089/jamp.2013.1056] - DOI - PubMed
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Steinkamp 1989 {published data only}
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Stephens 1983 {published data only}
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Stroobant 1985 {published data only}
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Tramper‐Stranders 2009 {published data only}
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Trapnell 2012 {published data only}
    1. McColley SA, Trapnell B, Kissner D, McKevitt M, Montgomery B, Rosen J, et al. Fosfomycin/tobramycin for inhalation (FTI): microbiological results of a phase 2 placebo‐controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa. Pediatric Pulmonology 2010;45 Suppl 33:338. [Abstract no: 334; CFGD Register: PI247c; CFGD Register: PI247c; ]
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Valerius 1991 {published data only}
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Wainwright 2008 {published data only}
    1. Byrnes CA, Vidmar S, Cheney JL, Carlin JB, Armstrong DS, Cooper PJ, et al. Prospective evaluation of respiratory exacerbations in children with cystic fibrosis from newborn screening to 5 years of age. Thorax 2013;68(7):643‐51. [CENTRAL: 904924; CFGD Register: PE167i; CRS: 5500125000000477; PUBMED: 23345574] - PMC - PubMed
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Wang 1984 {published data only}
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Westerman 2003 {published data only}
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Yasmin 1974 {published data only}
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References to studies awaiting assessment

Flume 2015 {published data only}
    1. Fischer R, Flume PA, Devanter DR, Polu K, Pecoraro M, Bhatt N, et al. Pulmonary exacerbations and changes in lung function in CF adults with P. aeruginosa treated with inhaled levofloxacin (Quinsair®) or tobramycin. Journal of Cystic Fibrosis 2016;51 Suppl 45:359. [Abstract no: 436; CENTRAL: 1262259; CRS: 5500135000001725]
    1. Flume P, Elborn JS, Polu K, Llorens L, Pecoraro ML, Bhatt N, et al. History of pulmonary exacerbations (PEx) as a predictor of response to nebulized levofloxacin compared with nebulized tobramycin. Journal of Cystic Fibrosis 2016;15 Suppl 1:S61. [Abstract no: 38; CENTRAL: 1171477; CFGD Register: PI283e; CRS: 5500135000001592]
    1. Flume P, Devanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI283c // PI240f // PI284c ; CRS: 5500135000001302]
    1. NCT01270347. Trial of aeroquin versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients [Phase 3, open‐label, randomized trial to evaluate the safety and efficacy of MP‐376 inhalation solution (Aeroquin) vs. tobramycin Iihalation solution (TIS) in stable CF patients]. clinicaltrials.gov/ct2/show/NCT01270347 05 January 2011. [CENTRAL: 1012530; CFGD Register: PI283a; CRS: 5500131000000187]
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Herrmann 2017 {published data only}
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