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Meta-Analysis
. 2017 Apr 25;4(4):CD004197.
doi: 10.1002/14651858.CD004197.pub5.

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Simon C Langton Hewer  1 , Alan R Smyth  2
Affiliations
Meta-Analysis

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Simon C Langton Hewer et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Respiratory tract infection with Pseudomonas aeruginosa occurs in most people with cystic fibrosis. Once chronic infection is established, Pseudomonas aeruginosa is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate.This is an update of a Cochrane review first published in 2003, and previously updated in 2006, 2009 and 2014.

Objectives: To determine whether antibiotic treatment of early Pseudomonas aeruginosa infection in children and adults with cystic fibrosis eradicates the organism, delays the onset of chronic infection, and results in clinical improvement. To evaluate whether there is evidence that a particular antibiotic strategy is superior to or more cost-effective than other strategies and to compare the adverse effects of different antibiotic strategies (including respiratory infection with other micro-organisms).

Search methods: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Most recent search: 10 October 2016.

Selection criteria: We included randomised controlled trials of people with cystic fibrosis, in whom Pseudomonas aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous antibiotics with placebo, usual treatment or other combinations of inhaled, oral or intravenous antibiotics. We excluded non-randomised trials, cross-over trials, and those utilising historical controls.

Data collection and analysis: Both authors independently selected trials, assessed risk of bias and extracted data.

Main results: The search identified 60 trials; seven trials (744 participants) with a duration between 28 days and 27 months were eligible for inclusion. Three of the trials are over 10 years old and their results may be less applicable today given the changes in standard treatment. Some of the trials had low numbers of participants and most had relatively short follow-up periods; however, there was generally a low risk of bias from missing data. In most trials it was difficult to blind participants and clinicians to treatment given the interventions and comparators used. Two trials were supported by the manufacturers of the antibiotic used.Evidence from two trials (38 participants) at the two-month time-point showed treatment of early Pseudomonas aeruginosa infection with inhaled tobramycin results in microbiological eradication of the organism from respiratory secretions more often than placebo, odds ratio 0.15 (95% confidence interval (CI) 0.03 to 0.65) and data from one of these trials, with longer follow up, suggested that this effect may persist for up to 12 months.One randomised controlled trial (26 participants) compared oral ciprofloxacin and nebulised colistin versus usual treatment. Results after two years suggested treatment of early infection results in microbiological eradication of Pseudomonas aeruginosa more often than no anti-pseudomonal treatment, odds ratio 0.12 (95% CI 0.02 to 0.79).One trial comparing 28 days to 56 days treatment with nebulised tobramycin solution for inhalation in 88 participants showed that both treatments were effective and well-tolerated, with no notable additional improvement with longer over shorter duration of therapy. However, this trial was not powered to detect non-inferiority or equivalence .A trial of oral ciprofloxacin with inhaled colistin versus nebulised tobramycin solution for inhalation alone (223 participants) failed to show a difference between the two strategies, although it was underpowered to show this. A further trial of inhaled colistin with oral ciprofloxacin versus nebulised tobramycin solution for inhalation with oral ciprofloxacin also showed no superiority of the former, with increased isolation of Stenotrophomonas maltophilia in both groups.A recent, large trial in 306 children aged between one and 12 years compared cycled nebulised tobramycin solution for inhalation to culture-based therapy and also ciprofloxacin to placebo. The primary analysis showed no difference in time to pulmonary exacerbation or proportion of Pseudomonas aeruginosa positive cultures. An analysis performed in this review (not adjusted for age) showed fewer participants in the cycled therapy group with one or more isolates of Pseudomonas aeruginosa, odds ratio 0.51 (95% CI 0.31 to 0.28). Using GRADE, the quality of evidence for outcomes was downgraded to moderate to very low. Downgrading decisions for Pseudomonas aeruginosa eradication and lung function were based on applicability (participants mostly children) and limitations in study design, with imprecision an additional limitation for lung function, growth parameters and adverse effects.

Authors' conclusions: We found that nebulised antibiotics, alone or in combination with oral antibiotics, were better than no treatment for early infection with Pseudomonas aeruginosa. Eradication may be sustained for up to two years. There is insufficient evidence to determine whether antibiotic strategies for the eradication of early Pseudomonas aeruginosa decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. Four trials comparing two active treatments have failed to show differences in rates of eradication of Pseudomonas aeruginosa. There have been no published randomised controlled trials that investigate the efficacy of intravenous antibiotics to eradicate Pseudomonas aeruginosa in cystic fibrosis. Overall, there is still insufficient evidence from this review to state which antibiotic strategy should be used for the eradication of early Pseudomonas aeruginosa infection in cystic fibrosis.

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Conflict of interest statement

Dr Langton Hewer is the lead investigator on the ongoing trial Torpedo‐CF: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis.

Prof Smyth declares relevant activities of membership of a Raptor steering committee, consultancies for Raptor, Gilead, Vertex, Roche and PTC. Actavis provide support for CF team educational activities.

Clarification statement added from Kevin Southern, Cystic Fibrosis Editor on 27 February 2020: This review was found by the Cochrane Funding Arbiters, post‐publication, to be noncompliant with theCochrane conflict of interest policy, which includes the relevant parts of theCochrane Commercial Sponsorship Policy. The review will be updated by February 2021; the update will have a majority of authors and lead author free of conflicts.

Current version (post‐publication): Dr Langton Hewer is the lead investigator on the ongoing trial Torpedo‐CF: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis, he has no financial conflicts of interest.

Prof Smyth declares relevant activities of membership of a Raptor steering committee, consultancies for Raptor, Gilead, Vertex, Roche and PTC. Actavis provide support for CF team educational activities.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 1 Positive respiratory culture for P aeruginosa (300 mg 2x daily).
1.2
1.2. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 2 Positive respiratory culture for P aeruginosa (80 mg 2x daily).
1.3
1.3. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 3 Positive respiratory culture for P aeruginosa (combined available case analysis).
1.4
1.4. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 4 Positive respiratory culture for P aeruginosa (combined) ‐ best case.
1.5
1.5. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 5 Positive respiratory culture for P aeruginosa (combined) ‐ worst case.
1.6
1.6. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 6 Weight (kg) ‐ change from baseline.
1.7
1.7. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 7 Adverse events.
1.8
1.8. Analysis
Comparison 1 Inhaled tobramycin versus placebo, Outcome 8 Modified Shwachmann score ‐ change from baseline.
2.1
2.1. Analysis
Comparison 2 Oral ciprofloxacin and inhaled colistin versus no treatment, Outcome 1 Proportion colonised with P aeruginosa.
3.1
3.1. Analysis
Comparison 3 Oral ciprofloxacin and inhaled colistin versus inhaled tobramycin, Outcome 1 Positive respiratory culture for P aeruginosa.
3.2
3.2. Analysis
Comparison 3 Oral ciprofloxacin and inhaled colistin versus inhaled tobramycin, Outcome 2 Adverse events.
4.1
4.1. Analysis
Comparison 4 Nebulised tobramycin 28 days versus 56 days, Outcome 1 Time to next isolation of P aeruginosa from BAL, sputum or oropharyngeal cultures.
4.2
4.2. Analysis
Comparison 4 Nebulised tobramycin 28 days versus 56 days, Outcome 2 Number of respiratory exacerbations.
4.3
4.3. Analysis
Comparison 4 Nebulised tobramycin 28 days versus 56 days, Outcome 3 Adverse events (up to 3 months).
4.4
4.4. Analysis
Comparison 4 Nebulised tobramycin 28 days versus 56 days, Outcome 4 Adverse events (over 3 months).
5.1
5.1. Analysis
Comparison 5 Inhaled colistin/oral ciprofloxacin versus inhaled tobramycin/oral ciprofloxacin, Outcome 1 Positive respiratory culture for P aeruginosa.
5.2
5.2. Analysis
Comparison 5 Inhaled colistin/oral ciprofloxacin versus inhaled tobramycin/oral ciprofloxacin, Outcome 2 FEV₁ % predicted (relative change from baseline).
5.3
5.3. Analysis
Comparison 5 Inhaled colistin/oral ciprofloxacin versus inhaled tobramycin/oral ciprofloxacin, Outcome 3 Microbiology status (post‐trial).
5.4
5.4. Analysis
Comparison 5 Inhaled colistin/oral ciprofloxacin versus inhaled tobramycin/oral ciprofloxacin, Outcome 4 Adverse events leading to trial discontinuation.
6.1
6.1. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 1 Participants with one or more isolates of P aeruginosa from respiratory tract.
6.2
6.2. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 2 FEV₁ % predicted ‐ change from baseline.
6.3
6.3. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 3 Weight (kg) ‐ change from baseline.
6.4
6.4. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 4 Height (cm) ‐ change from baseline.
6.5
6.5. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 5 Time to severe pulmonary exacerbation.
6.6
6.6. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 6 Participants with one or more severe pulmonary exacerbations.
6.7
6.7. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 7 Time to pulmonary exacerbation (any severity).
6.8
6.8. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 8 Participants with one or more pulmonary exacerbations (any severity).
6.9
6.9. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 9 Participants with new isolates of Stenotrophomonas maltophilia.
6.10
6.10. Analysis
Comparison 6 Cycled inhaled tobramycin versus culture‐based inhaled tobramycin, Outcome 10 Participants with one or more serious adverse event.
7.1
7.1. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 1 Participants with one or more isolates of P aeruginosa from respiratory tract.
7.2
7.2. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 2 FEV₁ % predicted ‐ change from baseline.
7.3
7.3. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 3 Weight (kg) ‐ change from baseline.
7.4
7.4. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 4 Height (cm) ‐ change from baseline.
7.5
7.5. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 5 Time to severe pulmonary exacerbation.
7.6
7.6. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 6 Participants with one or more severe pulmonary exacerbations.
7.7
7.7. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 7 Time to pulmonary exacerbation (any severity).
7.8
7.8. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 8 Participants with one of more pulmonary exacerbation (any severity).
7.9
7.9. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 9 Participants with new isolates of Stenotrophomonas maltophilia.
7.10
7.10. Analysis
Comparison 7 Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin, Outcome 10 Participants with one or more serious adverse event.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Gibson 2003 {published data only}
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Valerius 1991 {published data only}
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Alothman 2002 {published data only}
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Clancy 2013 {published data only}
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Elborn 2015 {published data only}
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    1. Elborn JS, Geller D, Conrad D, Aaron S, Smyth AR, Fischer R, et al. Phase 3 trial of inhaled levofloxacin (Aeruquinâ™, MP‐376, APT‐1026) vs. tobramycin inhalation solution (TIS) in intensively treated CF patients over 6 months. Journal of Cystic Fibrosis 2013;12 Suppl 1:S35. [Abstract no: WS17.6; CENTRAL: 867323; CFGD Register: PI262a; CRS: 5500100000011291]
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Flume 2015a {published data only}
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    1. Flume P. Trial of aeroquin versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. (www.clinicaltrials.gov) (accessed 21 Oct 2014) 2014. [CENTRAL: 1012530; CFGD Register: PI283a; CRS: 5500131000000187; 5500131000000187]
    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 : Official Journal of the European Cystic Fibrosis Society 2016;2015 Suppl 1:S61. [Abstract no: 38; CENTRAL: 1171477; CFGD Register: PI283e; CRS: 5500135000001592]
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials [abstract]. Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]
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Flume 2015b {published data only}
    1. Flume PA, Clancy JP, Retsch‐Bogart GZ, Tullis E, Bresnik M, Derchak PA, et al. Aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) continuous alternating therapy (CAT) for cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (PA) infection: a randomized, double‐blind, placebo‐controlled trial. Pediatric Pulmonology 2015;50 Suppl 41:352. [Abstract no: 428; CENTRAL: 1092171; CFGD Register: PI288; CRS: 5500135000001367]
Flume 2016 {published data only}
    1. Flume P. 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. www.clinicaltrials.gov (accessed 21 Oct 2014) 2014. [CENTRAL: 1012532; CFGD Register: PI284a; CRS: 5500131000000190; NCT01180634] - PubMed
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]
    1. Flume PA, VanDevanter 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] - PubMed
    1. Flume PA, VanDevanter 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] - PubMed
    1. Devanter D, Flume PA, Fleming R, Elborn J. How often is pulmonary exacerbation defined by ≥4 Fuchs criteria associated with antibiotic treatment?. Pediatric Pulmonlogy 2014;49 Suppl 38:356. [Abstract no: 388; CFGD Register: PI283b // PI284b]
Frederiksen 1997 {published data only}
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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. [CENTRAL: 507896; CFGD Register: PI187a ; CRS: 5500100000002694]
    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. [CENTRAL: 587235; CFGD Register: PI187c ; CRS: 5500100000002919; PUBMED: 17352404] - PubMed
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Geller 2011 {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 infection. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [Abstract no: 86; CENTRAL: 774683; CFGD Register: PI240a; CRS: 5500100000003504]
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]
    1. Flume PA, Geller DE, Loutit JS, Dudly MN, Conrad D, Mpex 204Sgroup. Effects of inhaled MP‐376 (Aeroquinâ„¢ 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; CENTRAL: 849020; CFGD Register: PI240b; CRS: 5500100000010582]
    1. Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ. Levofloxacin inhalation solution (MP‐376) in patients with cystic fibrosis with Pseudomonas aeruginosa. American Journal of Respiratory and Critical Care Medicine 2011;183(11):1510‐6. [CENTRAL: 800852; CFGD Register: PI240d; CRS: 5500100000010625] - PubMed
Gibson 2007 {published data only}
    1. Gibson RL, Emerson J, Mayer‐Hamblett N, Burns JL, McNamara S, Accurso FJ, et al. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatric Pulmonology 2007;42(7):610‐23. - PubMed
Goss 2009 {published data only}
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Online supplementary data to "Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection" [online. Thorax 2013;68(9):818‐25 online. [CFGD Register: PI222d // PI207f; CRS: 5500135000000003] - 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. [CENTRAL: 876398; CFGD Register: PI222c // PI207e ; CRS: 5500050000000084; PUBMED: 23749840] - 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 H, et al. 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; CFGD Register: PI222e // PI207g]
    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(S32):295. [CFGD CF Register: PI222a]
Griese 2002 {published data only}
    1. Griese M, Mueller I, Reinhardt D. Eradication of initial Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. European Journal of Medical Research 2002;7(2):79‐80. - PubMed
Heinzl 2002 {published data only}
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Kenny 2009 {published data only}
    1. Kenny S, Hall V, Goldsmith C, Moore J, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with CF. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39. [Abstract no: 158; MEDLINE: ]
    1. Kenny SL, Shaw TD, Downey DG, Moore JE, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with cystic fibrosis. BMJ Open Respiratory Research 2014;1:e000021. - PMC - PubMed
Konstan 2010 {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; CENTRAL: 744126; CFGD Register: PI227a; CRS: 5500100000003455]
    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; CENTRAL: 744127; CFGD Register: PI227b; CRS: 5500100000003456]
    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. [CENTRAL: 867122; CFGD Register: PI227e; CRS: 5500100000011272; PUBMED: 20963831] - PMC - PubMed
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    1. Novartis (NCT00125346). Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects (EVOLVE). Http://clinicaltrials.gov/ct2/show/NCT00125346 2010. [CENTRAL: 867467; CFGD Register: PI227c ; CRS: 5500100000006168]
Konstan 2011 {published data only}
    1. Chiron R, Geller DE, Angyalosi G, Debonnett L, Yadao A, Bader G, et al. Tobramycin powder for inhalation is effective in advanced stage CF lung disease: the EAGER trial. Journal of Cystic Fibrosis 2014;13 Suppl 2:S57. [Abstract no: 42; CENTRAL: 996576; CFGD Register: PI239k; CRS: 5500129000000011]
    1. Geller DE, Flume PA, Brockhaus F, Zhang J, Angyalosi G, He E, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP) versus TOBI in cystic fibrosis (CF) patients. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 82; CENTRAL: 776791; CFGD Register: PI239b; CRS: 5500100000003511]
    1. Geller DE, Flume PA, Konstan M, Angyalosi G, Higgins M. Microbiological and clinical response to tobramycin inhalation powder (TIPâ„¢) in cystic fibrosis patients with chronic Pseudomonas aeruginosa (Pa) infection [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [Abstract no: 82; CENTRAL: 848918; CFGD Register: PI239g; CRS: 5500100000010633]
    1. Geller DE, Nasr SZ, Piggott S, He E, Angyalosi G, Higgins M. Tobramycin inhalation powder in cystic fibrosis patients: response by age group. Respiratory Care 2014;59(3):388‐98. [CFGD Register: PI239l; CRS: 5500135000000283; PUBMED: 23983274] - PubMed
    1. Konstan M, Flume PA, Brockhaus F, Angyalosi G, He, E, et al. Safety and efficacy of tobramycin inhalation powder (TIP) in treating CF patients infected with Pseudomonas aeruginosa (Pa). Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 82; CENTRAL: 776166; CFGD Register: PI239a; CRS: 5500100000003510]
Konstan 2015 {published data only}
    1. Bilton D, Pressler T, Fajac I, Clancy JP, Minic P, Cipolli M, et al. Analysis of long‐term liposomal amikacin for inhalation in patients with cystic fibrosis and chronic infection from pseudomonas aeruginosa. Pediatric Pulmonology 2014;49 Suppl 38:317‐8. [Abstract no: 284; CENTRAL: 1012524; CFGD Register: PI280a; CRS: 5500131000000176]
    1. Bilton D, Pressler T, Fajac I, Clancy JP, Minic P, Cipolli M, et al. Analysis of long‐term use of liposomal amikacin for inhalation (LAI) in patients with cystic fibrosis (CF) who have chronic infection from Pseudomonas aeruginosa. Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S85. [Abstract no: 112; CENTRAL: 1099087; CFGD Register: PI280b; CRS: 5500135000001303]
    1. Konstan M, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, et al. Long‐term study of liposomal amikacin for inhalation (LAI) in patients with cystic fibrosis (CF) and chronic pseudomonas aeruginosa infection [abstract]. Pediatric Pulmonology 2015;50 Suppl 41:270, Abstract no: 212. [CENTRAL: 1092191; CFGD Register: PI280c; CRS: 5500135000001380]
Latzin 2008 {published data only}
    1. Latzin P, Fehling M, Bauernfeind A, Reinhardt D, Kappler M, Griese M. Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis. Journal of Cystic Fibrosis 2008;7(2):142‐6. [CFGD Register: PI209] - 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: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 1: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]
Littlewood 1985 {published data only}
    1. Littlewood JM, Miller MG, Ghoneim AT, Ramsden CH. Nebulised colomycin for early pseudomonal colonisation in cystic fibrosis [letter]. Lancet 1985;1(8433):865. - PubMed
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. [CENTRAL: 981442; CFGD Register: PI248b ; CRS: 5500125000000721; PUBMED: 24596456] - 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; CENTRAL: 848866; CFGD Register: PI248a ; CRS: 5500100000010543]
    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 2012 {published data only}
    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; CENTRAL: 848929; CFGD Register: PI249b; CRS: 5500100000010714]
    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 Suppl1:S74. [Abstract no: 69; CENTRAL: 867264; CFGD Register: PI249c; CRS: 5500100000011290]
    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; CENTRAL: 848928; CFGD Register: PI249a; CRS: 5500100000010713]
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 exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis. Pediatric Pulmonology 2009;44(S32):309. [Abstract no: 278; CFGD CF Register: PI220a]
    1. Oermann CM, McCoy KS, Retsch‐Bogart GZ, Gibson R, McKevitt M, Montgomery B. Effect of repeated exposure to aztreonam for inhalation solution (AZLI) therapy on cystic fibrosis respiratory pathogens. Pediatric Pulmonology 2009;44(Suppl 32):335. [Abstract no: 353; CFGD Register: PI220d]
    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; CFGD CF Register: PI220c]
    1. Oermann CM, McCoy KS, Retsch‐Bogart GZ, Gibson RL, Quittner AL, Montgomery AB. Adherence over multiple courses of Aztreonam for inhalation (AZLI): effect on disease‐ related endpoints in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA). Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 109; CFGD CF Register: PI220b]
    1. Oermann CM, Retsch‐Bogart GZ, Quittner AL, Gibson RL, McCoy KS, Montgomery AB, et al. An 18‐month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatric Pulmonology 2010;45(11):1121‐34. [CFGD Register: PI220e] - PMC - PubMed
Postnikov 2000 {published data only}
    1. Postnikov SS, Semykin SYU, Kapranov NI, Perederko LV, Polikarpova SV, Khamidullina KF. Evaluation of pefloxacin efficacy and tolerability in the treatment and prophylaxis of severe infections at the children with mucoviscidosis and aplastic anaemia. Antibiotiki i Khimioterapiia 2000;45(8):25‐30. [CFGD Register: PI171] - PubMed
Postnikov 2007 {published data only}
    1. Postnikov SS, Semykin SY, Polikarpova SV, Dubovik LG, Gracheva LA, Sagatelyan. A prospective trial on the efficacy and tolerability of twice‐daily dosing (TDD) versus once‐daily dosing (ODD) amikacin in cystic fibrosis patients. Journal of Cystic Fibrosis 2007;6 Suppl 1:S34. [CFGD CF Register: PI204]
Prayle 2013 {published data only}
    1. Prayle A, Jain K, Watson A, Smyth AR. Are morning doses of intravenous tobramycin less nephrotoxic than evening? Evidence from urinary biomarkers in the critic study. Pediatric Pulmonology 2013;48 Suppl 36:299. [Abstract no: 261; CENTRAL: 980338; CFGD Register: CO55 ; CRS: 5500125000000420]
Ramsey 1999 {published data only}
    1. Birnbaum HG, Greenberg P, Finkelstein S, Berndt E, Otto KL, Montgomery AB, et al. Economic analysis of hospitalization and home IV anti‐pseudomonal antibiotic use in CF patients on tobramycin solution for inhalation (TOBI®). Pediatric Pulmonology 1998;Suppl 17:273. [CENTRAL: 792738; CRS: 5500100000003553]
    1. Bowman CM. The long‐term use of inhaled tobramycin in patients with cystic fibrosis. Journal of Cystic Fibrosis 2002;1 Suppl 2(Suppl 2):S194‐8. [CENTRAL: 451888; CFGD Register: PI120cc; CRS: 5500100000002389] - PubMed
    1. Burns JL, Dalfsen JM, Shawar RM, Otto KL, Garber RL, Quan JM, et al. Effect of chronic intermittent administration of inhaled tobramycin on respiratory microbial flora in patients with cystic fibrosis. Journal of Infectious Diseases 1999;179(5):1190‐6. [CENTRAL: 161606; CRS: 5500100000000895; PUBMED: 10191222] - PubMed
    1. Casey S, Ramsey B, Borowitz D. Nutritional benefits of chronic intermittent Pseudomonas aeruginosa suppression with tobramycin solution for inhalation in adolescents. 13th International Cystic Fibrosis Congress; 2000 June 4‐8; Stockholm, Sweden. 2000:172. [CENTRAL: 302945; CRS: 5500100000001685]
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Ratjen 2001a {published data only}
    1. Ratjen F, Döring G, Nikolaizik WH. Effect of inhaled tobramycin on early Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Lancet 2001;358(9286):983‐4. - PubMed
Retsch‐Bogart 2008 {published data only}
    1. Burns JL, Stapp J, Lofland D, AIPhase 2SG. 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. [CENTRAL: 548338; CFGD Register: PI211a ; CRS: 5500100000002786]
    1. Retsch‐Bogart GZ, Burns JL, Otto KL, Liou TG, McCoy K, Oermann C, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology 2008;43(1):47‐58. [CENTRAL: 628521; CFGD Register: PI211c; CRS: 5500100000003193; PUBMED: 18041081] - PubMed
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    1. Retsch‐Bogart GZ, McCoy KS, Gibson RL, Oermann CM. Sustained improvement in pulmonary function following a 28‐day course of 75mg azli tid therapy. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 675920; CFGD Register: PI211d // PI213b; CRS: 5500100000003286]
Retsch‐Bogart 2009 {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; CENTRAL: 848913; CFGD Register: PI212g // PI213i ; CRS: 5500100000010623]
    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. [CENTRAL: 744120; CFGD Register: PI212e // PI213e ; CRS: 5500100000003449]
    1. McCoy KS, Retsch‐Bogart GZ, Gibson R, Oermann C, Braff MH, Montgomery AB. Relevance of established susceptibility breakpoints to clinical efficacy of inhaled antibiotic therapies in cystic fibrosis. Pediatric Pulmonology 2008;43 Suppl 31:351. [CENTRAL: 677646; CFGD Register: PI212b // PI213c; CRS: 5500100000003289]
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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; CENTRAL: 795021; CFGD Register: PI232a; CRS: 5500100000003587]
    1. Rietschel E, Staab D, Merkel N, Konigsbruggen S, Posselt H. Pharmacokinetics of continuous treatment with O.D. or B.I.D inhalation of tobramycin (TOBI™) via Pari Eflow™ Rapid. Pediatric Pulmonology 2010;45 Suppl 33:320. [Abstract no: 283; CENTRAL: 849031; CFGD Register: PI232c; CRS: 5500100000010629]
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Ruddy 2013 {published data only}
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References to studies awaiting assessment

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