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Meta-Analysis
. 2018 Oct 30;10(10):CD008319.
doi: 10.1002/14651858.CD008319.pub3.

Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis

Sherie Smith  1 , Nicola J Rowbotham, Edward Charbek
Affiliations
Free PMC article
Meta-Analysis

Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis

Sherie Smith et al. Cochrane Database Syst Rev. .
Free PMC article

Update in

Abstract

Background: Cystic fibrosis is a genetic disorder in which abnormal mucus in the lungs is associated with susceptibility to persistent infection. Pulmonary exacerbations are when symptoms of infection become more severe. Antibiotics are an essential part of treatment for exacerbations and inhaled antibiotics may be used alone or in conjunction with oral antibiotics for milder exacerbations or with intravenous antibiotics for more severe infections. Inhaled antibiotics do not cause the same adverse effects as intravenous antibiotics and may prove an alternative in people with poor access to their veins. This is an update of a previously published review.

Objectives: To determine if treatment of pulmonary exacerbations with inhaled antibiotics in people with cystic fibrosis improves their quality of life, reduces time off school or work and improves their long-term survival.

Search methods: We searched the Cochrane Cystic Fibrosis Group's Cystic Fibrosis Trials Register. Date of the last search: 03 October 2018.We searched ClinicalTrials.gov, the Australia and New Zealand Clinical Trials Registry and WHO ICTRP for relevant trials. Date of last search: 09 October 2018.

Selection criteria: Randomised controlled trials in people with cystic fibrosis with a pulmonary exacerbation in whom treatment with inhaled antibiotics was compared to placebo, standard treatment or another inhaled antibiotic for between one and four weeks.

Data collection and analysis: Two review authors independently selected eligible trials, assessed the risk of bias in each trial and extracted data. They assessed the quality of the evidence using the GRADE criteria. Authors of the included trials were contacted for more information.

Main results: Four trials with 167 participants are included in the review. Two trials (77 participants) compared inhaled antibiotics alone to intravenous antibiotics alone and two trials (90 participants) compared a combination of inhaled and intravenous antibiotics to intravenous antibiotics alone. Trials were heterogenous in design and two were only available in abstract form. Risk of bias was difficult to assess in most trials, but for all trials we judged there to be a high risk from lack of blinding and an unclear risk with regards to randomisation. Results were not fully reported and only limited data were available for analysis.Inhaled antibiotics alone versus intravenous antibiotics aloneOnly one trial (n = 18) reported a perceived improvement in lifestyle (quality of life) in both groups (very low-quality of evidence). Neither trial reported on time off work or school. Both trials measured lung function, but there was no difference reported between treatment groups (very low-quality evidence). With regards to our secondary outcomes, one trial (n = 18) reported no difference in the need for additional antibiotics and the second trial (n = 59) reported on the time to next exacerbation. In neither case was a difference between treatments identified (both very low-quality evidence). The single trial (n = 18) measuring adverse events and sputum microbiology did not observe any in either treatment group for either outcome (very low-quality evidence).Inhaled antibiotics plus intravenous antibiotics versus intravenous antibiotics aloneNeither trial reported on quality of life or time off work or school. Both trials measured lung function, but found no difference between groups in forced expiratory volume in one second (one trial, n = 28, very low-quality evidence) or vital capacity (one trial, n = 62). Neither trial reported on the need for additional antibiotics or the time to the next exacerbation; however, one trial (n = 28) reported on hospital admissions and found no difference between groups. Both trials reported no difference between groups in adverse events (very low-quality evidence) and one trial (n = 62) reported no difference in the emergence of antibiotic-resistant organisms (very low-quality evidence).

Authors' conclusions: There is little useful high-level evidence to judge the effectiveness of inhaled antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis. The included trials were not sufficiently powered to achieve their goals. Hence, we are unable to demonstrate whether one treatment was superior to the other or not. Further research is needed to establish whether inhaled tobramycin may be used as an alternative to intravenous tobramycin for some pulmonary exacerbations.

PubMed Disclaimer

Conflict of interest statement

No conflicts of interest were reported by Sherie Smith or Ed Charbek

Nicola J Rowbotham is an NIHR academic clinical fellow. She has received non‐financial support (travel and accommodation) for conference attendance from TEVA.

Previous author team

Dr Gerard Ryan received funds for research for a multicentre industry‐sponsored trial of aztreonam. Dr Ryan worked in a CF centre that contributed participants to the trial with funding going to the Lung Institute of Western Australia (LIWA) for research staff. No funding went to the CF centre.

Figures

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1
PRISMA flow diagram
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2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

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    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. Online Supplement to 'Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis' [online]. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841 Online. [CFGD Register: PI151e] - 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):841‐9. [CFGD Register: PI151d] - PubMed
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Gibson 2004 {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. [CENTRAL: 876398; CFGD Register: PI207e // PI222c; 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; CENTRAL: 848916; CFGD Register: PI207d // PI222b ; CRS: 5500100000010628]
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Griffith 2008 {published data only}
    1. Geller DE, Flume P, Schwab R, Fornos P, Conrad DJ, Morgan E, et al. A phase safety, tolerability and pharmacokinetic (PK) study of MP‐376 (levofloxacin solution for inhalation) in stable cystic fibrosis (CF) patients. Pediatric Pulmonology 2008;43(Suppl 1):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. [CENTRAL: 643120; CFGD Register: PI210a; CRS: 5500100000003230]
    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. Morgan EE, Dudley MN. Phase I, single and multi‐dose, placebo controlled, randomized, dose‐escalation study to evaluate the safety, tolerability and PK profile of MP‐376 using the PARI eFlow nebulizer for 14 days to CF patients. ClinicalTrials.gov (accessed 08 December 2010). [Clinicaltrials.gov: NCT00503490]
    1. Stockmann C, Hillyard B, Ampofo K, Spigarelli MG, Sherwin CM. Levofloxacin inhalation solution for the treatment of chronic Pseudomonas. 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 [abstract]. Proceedings of the Thoracic Society of Australia & New Zealand Annual Scientific Meeting; 2003 April 4‐9; Adelaide, Australia. 2003:Abst P139. [CFGD Register: PI184]
Herrmann 2017 {published data only}
    1. Herrmann G, Freitag E, Kiefer L, Bender V, Adams C, Graepler‐Mainka U, et al. Combined dry powder tobramycin and nebulized colistin versus colistin inhalation in CF patients ‐ a randomised, open label phase III clinical study. Journal of Cystic Fibrosis 2017;16 Suppl 1:S54. [CFGD Register: PI294]
Hodson 2002 {published data only}
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    1. Hodson ME, Gallagher CG, Govan JRW, the PL‐TNDS‐101CTG. Randomised UK/Eire clinical trial of the efficacy and safety of tobramycin 300 mg/5 mL nebuliser solution or nebulised colistin. Proceedings of the 13th International Cystic Fibrosis Congress; 2000 June 4‐8; Stockholm. 2000:145. [CFGD Register: PI153a]
Huls 2000 {published data only}
    1. App EM, Huls G, Bittner‐Dersch P, Stolz S, Lindemann H, Matthys H. Impaired lung function influences the serum concentration of inhaled drugs in cystic fibrosis. Pediatric Pulmonology 2000;30(Suppl 20):279‐80. [CFGD Register: PI156b]
    1. Huls G, App EM, Bittner‐Dersch P, Stolz S, Lindemann H. Impaired lung function influences the serum concentration of inhaled drugs in cystic fibrosis. Proceedings of the 13th International Cystic Fibrosis Congress, 4‐8 June 2000, Stockholm, Sweden. 2000:177. [CFGD Register: PI156a]
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. 1985:147. [CFGD Register: PI131]
Jensen 1987 {published data only}
    1. Jensen T, Pedersen SS, Garne S, Heilmann C, Hoiby N, Koch C. Colistin inhalation therapy in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. Journal of Antimicrobial Chemotherapy 1987;19(6):831‐8. [CFGD Register: PI51] - PubMed
Kapranov 1995 {published data only}
    1. Kapranov NI, Belousov YB, Kashyrskaya NY, Smirnova EY. Quinoline therapy in children with cystic fibrosis. Proceedings of the 20th European Cystic Fibrosis Conference; 1995 June 18‐21; Brussels, Belgium. 1995:P19. [CENTRAL: 291377; CFGD Register: PI104; CRS: 5500100000001422]
Kenny 2009 {published data only}
    1. Kenny S, Hall V, Goldsmith C, Moore J, Rendall JC, Elborn JS. Eradication of new Pseudomonas aeruginosa in adults with CF. Journal of Cystic Fibrosis 2009;8(Suppl 2):S39. [CFGD Register: PI229]
Konstan 2010 {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, Angylosi 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; CFGD Register: PI239b] - PMC - PubMed
    1. Geller DE, Flume PA, Konstan M, Angyalosi G, Higgins M. Microbiological and clinical response to tobramycin inhalation powder (TIP™) in cystic fibrosis patients with chronic Pseudomonas aeruginosa (Pa) infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [Abstract no.: 82; CFGD Register: PI239g] - PMC - PubMed
    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] - PubMed
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Konstan 2011 {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:no pagination. [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 2011;46(3):230‐8. [CFGD Register: PI227e] - PMC - PubMed
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    1. Novartis. A randomised 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 (accessed 08 December 2010). [CFGD Register: PI227c; NCT00125346]
Kun 1984 {published data only}
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    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. Proceedings of 22nd European Cystic Fibrosis Conference; 1998 June 13‐19; Berlin, Germany. 1998:120. [CFGD Register: PI128a]
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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
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Mainz 2014 {published data only}
    1. Mainz J. Nasal inhalation of tobramycin by the Pari sinus nebuliser in patients with cystic fibrosis and Pseudomonas aeruginosa colonization in the upper airways. ClinicalTrials.gov (accessed 08 December 2010). [Clinicaltrials.gov: NCT00774072]
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    1. Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmuller 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. [CFGD Register: PI248c] - PubMed
Mazurek 2011 {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(1 Meeting Abstracts):no pagination. [CFGD Register: PI249e]
    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
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    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. [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; CENTRAL: 848913; CFGD Register: PI212g // PI213i; CRS: 5500100000010623]
    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;178:921‐8. [CFGD Register: PI212c] - PMC - PubMed
    1. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch‐Bogart GZ, Montgomery AB. Online Data Supplement to 'Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis' [online]. American Journal of Respiratory and Critical Care Medicine 2008;178(9):921‐8. [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. [CFGD Register: PI212e // PI213e]
Nasr 2006 {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. [CENTRAL: 518355; CFGD Register: DG2a ; CRS: 5500100000002727]
    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. [CENTRAL: 573172; CFGD Register: DG2c; CRS: 5500100000002876; EMBASE: 2006604093; PUBMED: 17068818] - PubMed
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    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. [CENTRAL: 752249; CFGD Register: DG2e; CRS: 5500125000000357; PUBMED: 20425851] - PubMed
    1. Nasr SZ, Sakmar E, Eckhardt BP, Strouse PJ. High resolution computerized tomography (HRCT) of the chest vs. pulmonary function testing utility in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis. Pediatric Pulmonology 2008;43 Suppl 31:366. [CENTRAL: 690468; CFGD Register: DG2d; CRS: 5500100000003327]
Nathanson 1985 {published data only}
    1. Nathanson I, Cropp GJA, Li P, Neter E. Effectiveness of aerosolized gentamicin in cystic fibrosis (CF). Cystic Fibrosis Club Abstracts; 1985. 1985; Vol. 28:145. [CENTRAL: 291475; CFGD Register: PI130; CRS: 5500100000001502]
Nikolaizik 1996 {published data only}
    1. Nikolaizik WH, Jenni‐Galovic V, Schoni MH. Bronchial constriction after nebulized tobramycin preparations and saline in patients with cystic fibrosis. European Journal of Pediatrics 1996;155(7):608‐11. - PubMed
Nikolaizik 2005 {published data only}
    1. Nikolaizik WH, Vietzke D, Ratjen F. A pilot study to compare tobramycin 80 mg injectable preparation with 300 mg solution for inhalation in cystic fibrosis patients. Canadian Respiratory Journal 2008;15(5):259‐62. [CFGD Register: PI191c] - PMC - PubMed
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Nikonova 2010 {published data only}
    1. Nikonova VS, Kashirskaya NY, Kapranov NI. Efficacy and safety of tobramycin and colistin for inhalation in children with cystic fibrosis from Moscow region. Journal of Cystic Fibrosis 2010;9 Suppl 1:S54. [Abstract no.: 210; CENTRAL: 774753; CFGD Register: PI242; CRS: 5500100000003505]
Noah 2010 {published data only}
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Nolan 1982 {published data only}
    1. Nolan G, McIvor P, Levison H, Fleming PC, Corey M, Gold R. Antibiotic prophylaxis in cystic fibrosis: inhaled cephaloridine as an adjunct to oral cloxacillin. Journal of Pediatrics 1982;101(4):626‐30. [CFGD Register: PI110] - PubMed
Novartis 2010 {published data only}
    1. Novartis. A randomized, double‐blind, placebo‐controlled, crossover multi‐center study to assess the efficacy and safety of inhaled tobramycin nebuliser solution (TOBI®) for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years. ClinicalTrials.gov (accessed 08 December 2010). [Clinicaltrials.gov: NCT01082367; EARLY trial]
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; CENTRAL: 735839; CRS: 5500100000003411]
    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; CENTRAL: 744123; CRS: 5500100000003452]
    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; CENTRAL: 744122; CRS: 5500100000003451]
    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; CENTRAL: 744121; CRS: 5500100000003450]
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Poli 2005 {published data only}
    1. Poli G, Acerbi D, Pennini R, Soliani Raschini A, Bianco F, Corrado M, et al. Clinical pharmacology study of a new tobramycin solution for nebulisation. Journal of Cystic Fibrosis 2006;5(Suppl):S43. [CFGD Register: PI195b]
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Proesmans 2013 {published data only}
    1. Proesmans M, Boulanger L, Vermeulen F, Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ ciprofloxacin. Journal of Cystic Fibrosis 2008;7(Suppl 2):S64. [CFGD Register: PI208a]
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    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. [CFGD Register: PI120f]
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Regelmann 1990 {published data only}
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Retsch‐Bogart 2007 {published data only}
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Retsch‐Bogart 2008 {published data only}
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Rietschel 2009 {published data only}
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Rosenfeld 2006 {published data only}
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Ruddy 2013 {published data only}
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Schaad 1997 {published data only}
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Schelstraete 2009 {published data only}
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Schuster 2013 {published data only}
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Stass 2008 {published data only}
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Stead 1987 {published data only}
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Stroobant 1985 {published data only}
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Taccetti 2012 {published data only}
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Tramper‐Stranders 2009 {published data only}
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Treggiari 2011 {published data only}
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Tullis 2014 {published data only}
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Valerius 1991 {published data only}
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Wainwright 2002 {published data only}
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Wiesemann 1998 {published data only}
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References to studies awaiting assessment

Postnikov 2007 {published data only}
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Semykin 2010 {published data only}
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References to ongoing studies

Prevotat 2018 {published data only}
    1. NCT03066453. Evaluation of short antibiotic combination courses followed by aerosols in cystic fibrosis (TOBRAMUC). clinicaltrials.gov/ct2/show/NCT03066453 (first received 28 February 2017).

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