Inhaled Colistimethate Sodium in the Management of Patients with Bronchiectasis Infected by Pseudomonas aeruginosa: A Narrative Review of Current Evidence

Figures & data

Table 1 Indication for Inhaled Antibiotic Treatment in Patients with Bronchiectasis and Primary Bronchial Infection (Presented in Chronological Order of Their Publication Date)

First Author Medical Society Year of Publication	Recommendations	Protocols	Inhaled Antibiotics Used	Comments
Chang, AB Thoracic Society of Australia and New Zealand Guidelines 2015^Citation92	When P. aeruginosa is first detected, consider discussion with a specialist in this field regarding the suitability of eradication treatment. No recommendations for other PPMs.	No protocols.	No antibiotics listed.	No comments.
Polverino, E European Respiratory Society Guidelines 2017^Citation3	Patients with a new isolation of P. aeruginosa should be offered eradication antibiotic treatment. Do not offer eradication antibiotic treatment to patients following new isolation of pathogens other than P. aeruginosa.	Three possible and alternative P. aeruginosa eradication treatment pathways based on usual clinical practice.	Colistin or tobramycin solution for inhalation or gentamicin*.	There is no clear evidence to support one regimen over another. After each step it is recommended to repeat sputum sampling and to progress to the next step if the culture remains positive.
Al-Jahdali, H Saudi Thoracic Society Guidelines 2017^Citation93	No recommendation.	No protocols.	No antibiotics listed.	There is a need for more studies on the effectiveness of P. aeruginosa eradication.
Martínez-García, MA Spanish Respiratory Society Guidelines 2018^Citation2	Eradication of P. aeruginosa should be attempted. Eradication of MRSA should be attempted. For other PPMs, the decision to apply an eradication treatment in initial infection should be made on an individual basis, according to the patient’s symptoms and the PPMs in question.	Several protocols for P. aeruginosa eradication. Several protocols for MRSA eradication.	Aztreonam lysine solution for inhalation, colistin or tobramycin solution for inhalation. One includes inhaled vancomycin*. Gentamicin* or any of the inhaled antibiotics used in chronic P. aeruginosa infection.	No eradication protocol has shown superiority over another.
Hill, AT British Thoracic Society Guidelines 2019^Citation4	Offer eradication antibiotic treatment to patients with clinical deterioration and a new growth of P. aeruginosa. No recommendation with inhaled antibiotics for PPMs other than P. aeruginosa.	Several protocols for P. aeruginosa eradication, according to the clinical situation.	Colistin, gentamicin* or tobramycin* or tobramycin solution for inhalation.	Discuss with patients the potential risks and benefits of starting eradication treatment versus clinical observation in the context of stable bronchiectasis.
Pereira, MC Brazilian Consensus 2019^Citation94	Immediately following the first identification of P. aeruginosa, the patient should be treated with a systemic antipseudomonal antibiotic combined with an inhaled antibiotic. With regard to other PPMs, there is insufficient evidence to justify the adoption of eradication protocols in this context.	Suggest a 14- to 21-day regimen of systemic antibiotic therapy in conjunction with a longer than 3-month course of inhaled antibiotic. No protocols listed.	Colistin, gentamicin* or tobramycin (solution for inhalation). No antibiotics listed.	If inhaled antibiotics are unavailable, treatment should consist only of systemic antibiotics. In selected cases, characterized by progressive functional decline and/or severe exacerbation related to the first identification of a PPMs, eradication should be undertaken.

Note: *Intravenous formulation administered via inhalation.

Abbreviations: P. aeruginosa, Pseudomonas aeruginosa; MRSA, methicillin-resistant Staphylococcus aureus; PMM, potentially pathogenic microorganisms.

Table 2 Indication for Inhaled Antibiotic Treatment in Patients with Bronchiectasis and Chronic Bronchial Infection (Presented in Chronological Order of Their Publication Date)

First Author Medical Society Year of Publication	Recommendations	Protocols	Inhaled Antibiotics Used	Comments
Chang, AB Thoracic Society of Australia and New Zealand Guidelines 2015^Citation92	Long-term nebulised antibiotics against P. aeruginosa infection should not be prescribed routinely. No recommendations in patients with chronic bronchial infection due to other PPMs.	Consider a therapeutic trial in patients with frequent exacerbations and/or P. aeruginosa infection.	No antibiotics listed.	No comments.
Polverino, E European Respiratory Society Guidelines 2017^Citation3	Authors suggest long-term treatment with an inhaled antibiotic for patients with chronic P. aeruginosa infection and three or more exacerbations per year. Authors suggest long-term treatment with an inhaled antibiotic for patients not infected with P. aeruginosa in whom neither oral antibiotic prophylaxis nor macrolide treatment is tolerated or effective.	For individuals with P. aeruginosa, the currently available evidence supports continuous use of nebulized colistin or gentamicin.	For any PPMs (including P. aeruginosa): colistin or gentamicin*. Nebulized aztreonam is not recommended.	Long-term antibiotic therapy should be considered only after optimization of general aspects of bronchiectasis management.
Al-Jahdali, H Saudi Thoracic Society Guidelines 2017^Citation93	Benefits of long-term inhaled antibiotics are not clear and authors do not recommend their use.	No protocols listed.	Tobramycin (solution for inhalation), gentamicin* or colistin.	Authors do not recommend routine use of inhaled antibiotics, except in very select cases with chronic P. aeruginosa infection, frequent exacerbation, and significant morbidity.
Martínez-García, MA Spanish Respiratory Society Guidelines 2018^Citation2	Prolonged antibiotic treatment is recommended in the following situations: In all patients who present chronic bronchial P. aeruginosa infection. In patients with chronic bronchial infection due to other PPMs, who also present at least 2 exacerbations or 1 hospitalization due to exacerbation during the previous year, marked decline in lung function, or deterioration in quality of life evidenced by an increase in sputum volume or purulence, dyspnea, or cough.	Several protocols for P. aeruginosa and other PPMs in chronic bronchial infection.	Chronic bronchial P. aeruginosa: nebulized aztreonam or **ciprofloxacin (dry powder or solution for inhalation) or colistin (dry powder or solution for inhalation) or gentamicin* or tobramycin (dry powder or solution for inhalation). Chronic MRSA infection should be treated with vancomycin*. Chronic Stenotrophomonas maltophilia infection should be treated with colistin. Chronic infection with other PPMs should be treated with gentamicin* or any of the inhaled antibiotics used in chronic P. aeruginosa infection.	Inhaled rather than systemic antibiotics are strongly recommended. Treatment protocols for chronic infection are varied and none has demonstrated superiority over another.
Hill, AT British Thoracic Society Guidelines 2019^Citation4	Consider long-term antibiotics in patients who experience 3 or more exacerbations per year.	P. aeruginosa-infected patients: Colistin. Consider inhaled gentamicin as a second line. Non-P. aeruginosa-infected patients: Consider inhaled gentamicin* as a second line alternative to macrolides.	Gentamycin*, tobramycin (solution for inhalation) or colistin.	Thresholds for long term treatment may be reduced if the patient is symptomatic between exacerbations and/or the exacerbations respond poorly to treatment and/or the patient is at high risk of severe exacerbation.
Pereira, MC Brazilian Consensus 2019^Citation94	Patients with chronic P. aeruginosa infection and exacerbations should be treated with long-term inhaled antibiotics. In patients with chronic infection with PPMs other than P. aeruginosa, the lack of evidence does not allow any recommendation of the use of inhaled antibiotics.	No protocols listed.	Colistin, gentamicin*, tobramycin (dry powder or solution for inhalation).	The choice will depend on the availability of and access to medication.

Note: *Intravenous formulation administered via inhalation; **Not yet on the market.

Abbreviations: P. aeruginosa, Pseudomonas aeruginosa; MRSA, methicillin-resistant Staphylococcus aureus; PMM, potentially pathogenic microorganisms.

Table 3 Studies on the Efficacy/Effectiveness and Safety of Colistin in Bronchiectasis Patients, in Chronological Order According to the Year of Publication

First Author Country Publication Year	Type of Study	Objectives of the Study	Inclusion Criteria	Number and Characteristics of Patients Included	Dose and Duration of the Inhaled Treatment	Efficacy / Effectiveness Results	Antibiotic Resistance and Safety Results
Steinfort, DP Australia 2007^Citation52	Prospective, non-controlled.	To examine the utility of long-term nebulized colistin in patients with COPD and non-CF bronchiectasis.	Patients with bronchiectasis or severe COPD (FEV1<40%), as well as repeated isolates of multi-drug resistant Gram-negative bacteria in sputum cultures with the following clinical features: High rates of exacerbations or admissions to hospital. Difficulty with symptom control. High volume of sputum production in between exacerbations.	18 patients: 14 idiopathic bronchiectasis. 4 severe COPD/chronic infective bronchitis. 66% women Age: 69 ± 10.2 years.	Nebulized colistin 30 mg daily Duration: 41 ± 25.6 months (6–116).	Compared with the previous period, after the start of colistin treatment, significant differences were found in: Mean decline in FEV1 was slower. Mean decline in FVC was slower. Improvement in patient-reported quality of life using a visual analogue scale. Three patients showed clearance of Pseudomonas spp. at the end of the study period.	No resistance to colistin was recorded among the bacterial isolates obtained. Patients in the cohort reported no side effects. One patient ceased colistin because of perceived ineffectiveness.
Dhar, R United Kingdom 2010^Citation53	Retrospective.	To assess the efficacy of nebulized colomycin in P. aeruginosa-colonized bronchiectasis patients.	Patients with bronchiectasis colonized by P. aeruginosa who had received a minimum of 6 months of treatment. Patients who received concomitant prophylactic macrolide treatment for >4 weeks were excluded.	19 patients 53% women Mean age: 66 years.	Nebulized colomycin 1–2 MU twice daily Mean duration: 21.2 months (6–39).	After initiation of colomycin, there was a significant reduction in: Exacerbations/year. Hospitalizations/year. Sputum P aeruginosa positivity/year. Sputum volume.	NS
Berlana, D Spain 2011^Citation54	Prospective, observational cohort study.	To compare clinical and microbiologic outcomes in non-CF patients with P. aeruginosa bronchial colonization who were receiving nebulized colistin or colistin + tobramycin with those who were receiving tobramycin alone.	Patients with bronchiectasis or COPD with chronic P. aeruginosa bronchial colonization who were receiving long-term inhaled antibiotic (minimum 12 weeks) with colistin and/or tobramycin, between January 2004 and December 2008. Patients with treatment adherence lower than 80% were excluded.	81 patients with 97 courses of inhaled antibiotic: colistin (n=31), colistin + tobramycin (n=16) or tobramycin (n=50). 86% bronchiectasis 14% COPD 45% women Age: 62.5 ± 14.3 years.	Nebulized colistin 1–2 MU every 12h and/or tobramycin 100–200 mg every 12h. Duration: 577.9 ± 470.1 days.	No significant differences between colistin and tobramycin were found in the mean number of hospital admissions, duration of hospitalizations, duration of antibiotic treatment, mortality, or emergence of other opportunistic microorganisms. Patients treated with both inhaled antibiotics had significantly fewer days of hospitalization and fewer days of antibiotic use than those treated with tobramycin alone.	Emergence of resistance to colistin was lower than resistance to tobramycin. The overall frequency of adverse events was 40% (30.3% as probable and 9.8% as definite), mainly respiratory. Events leading to discontinuation in 18% (colistin 26%, tobramycin 13%). No significant differences between colistin and tobramycin were found in adverse events.
Tabernero Huguet, E Spain 2015^Citation59	Prospective, controlled, open label study.	To assess the effectiveness of inhaled colistin in reducing hospital readmissions in elderly patients with bronchiectasis and chronic bronchial P. aeruginosa infection.	Elderly patients (>65 years) with bronchiectasis, in whom at least one month after admission and correct treatment with two intravenous antibiotics for 15 days, P. aeruginosa isolation persisted in culture with the stable patient. Patients with dementia, or associated terminal illness, were excluded.	38 patients: 19-patient control group: treatment optimization + comprehensive (standardized education and respiratory physiotherapy). 19-patient intervention group: in addition to the above, inhaled colistin. Women: 22% (control group) and 15% (intervention group). Mean age: 78.1 years (control group); 77.7 years (intervention group).	Nebulized colistin 1 MU every 12h with i-neb nebulizer. Duration: 1 year.	There were no differences in the annual number of hospital admissions between the control group and the colistin group, or in the length of the hospitalization. There were no differences in lung function or clinical symptoms between both groups. P. aeruginosa was eradicated in 45% of the intervention group, and in only one of the control groups (P<0.05).	No significant changes were observed in P. aeruginosa antibiotic sensitivity or in sputum flora. Five patients (25%) stopped the nebulized treatment because of adverse effects.
Bruguera-Avila, N Spain 2017^Citation61	Retrospective	To analyze whether the introduction of nebulized colistin in patients with COPD and infection with P. aeruginosa is associated with a decrease of the number and duration of severe exacerbations.	Patients with severe COPD (FEV1<50%), frequent exacerbations and chronic/intermittent bronchial colonization by P. aeruginosa who received nebulized colistin for at least 3 months, between January 2010 and December 2014. Patients with asthma, malignancy, unstable heart disease, or a main diagnosis of bronchiectasis were excluded.	36 patients (75% had bronchiectasis). 0% women. Age: 72.7 ± 2.1 years.	Nebulized colistin 1 MU every 12h with i-neb nebulizer. Duration: 10.7±4.2 months.	After initiation of colomycin, there was a significant reduction in: Number of admissions. Duration of admissions. These results were similar in patients with and without bronchiectasis. No pre-post differences were detected in the number of moderate exacerbations not requiring admission. Eradication of P. aeruginosa in 38.9% of patients.	No differences in the culture results during follow-up were found between patients with and without bronchiectasis. Resistance to colistin was only reported in bacteria known as constitutively resistant. Four patients reported bronchospasm (11.1%) and three of these dropped out for this reason (8.4%).
Blanco-Aparicio, M Spain 2019^Citation55	Prospective, observational cohort study.	To evaluate the efficacy of an antibiotic eradication protocol for P. aeruginosa infection consisting of the administration of systemic antibiotics followed by inhaled colistin for 12 months in patients with NCFB.	Patients with bronchiectasis, ≥1 positive culture for P. aeruginosa, follow-up for at least 1 year after eradication treatment. Patients without systemic antibiotic treatment (oral or IV) prior to starting inhaled antibiotic, and those who achieved successful P. aeruginosa eradication only with systemic antibiotic treatment, were excluded.	67 patients. Women: 40.3%. Age: 67.2 ± 14.6 years.	Eradication protocol: Oral ciprofloxacin (750 mg twice daily) for 3 weeks OR IV tobramycin (5 mg/kg) plus beta-lactam antipseudomonal antibiotics for 2 weeks. - Nebulized colistin 1 MU every 12h with i-neb nebulizer, for 1 year.	After initiation of colistin, there was a significant reduction in: Number of exacerbations. Number of hospital admissions. Number of antibiotic cycles. Eradication of P. aeruginosa was achieved in: 61.2% after 3 months; 50.7% after 6 months; 43.3% after 9 months; 40.3% after 1 year. No significant differences in the eradication rate of P. aeruginosa in the short or long term, depending on the number of previous positive sputum cultures.	Mild adverse effects (cough and/or wheezing) were reported by five (7.5%) patients during the first month of treatment but did not result in discontinuation of therapy.
López-Gil, MM Spain 2019^Citation56	Retrospective	To evaluate whether treatment with nebulized colistin for at least 6 months reduces the number of admissions and visits to the emergency department.	Patients with bronchiectasis with CBI by P. aeruginosa, who had received inhaled colistin for at least 6 months. Patients with lung transplant or interstitial lung disease were excluded.	44 patients. Women: 45.5%. Age: 71.4 ± 11.3 years.	Nebulized colistin 1 MU every 12h with i-neb nebulizer. Duration: 18.27 months.	After initiation of colistin, there was a significant reduction in: P. aeruginosa positive cultures. Number of antibiotic cycles and days of antibiotic treatment. Number of emergency room visits, admissions, and hospitalization days.	There was a slight (not significant) tendency to isolate microorganisms other than P. aeruginosa during treatment, especially S. aureus. 90.9% of patients did not experience any adverse effects attributable to nebulized colistin.
Montón C et al Spain 2019^Citation63	Retrospective	To establish whether a combination of nebulized colistin plus continuous azithromycin in severe COPD patients with CBI due to P. aeruginosa reduces the frequency of exacerbations, and to assess its microbiological effect.	Patients with severe COPD and chronic bronchial infection by P. aeruginosa treated with nebulized colistin for at least 3 months between 2005 and 2015, in combination with long-term oral azithromycin. Patients with a main diagnosis of bronchiectasis were excluded.	32 patients (78% had bronchiectasis). Women: 0% Age: 74.7 ± 7 years.	Nebulized colistin 1–2 MU every 12h with Jet nebulizer or 0.5–1 MU every 12h with I-neb nebulizer. Median duration: 17 months (7–24).	Comparing the 24 months prior to the start of treatment with the subsequent 24 months, the following were observed: Reduction in COPD exacerbations (38.3%), hospitalizations (41.5%), and days of admission (41.9%). P. aeruginosa sputum isolates in both exacerbations and stable phase. - Eradication of P. aeruginosa in 47% of patients in the first year of follow-up; 28% patients remained negative after two years.	P. aeruginosa sputum isolates were multidrug-resistant to antibiotics in 43.7% of the patients at baseline; this percentage did not increase throughout follow-up. No resistance to colistin was observed. 3 patients (9%) presented bronchospasm as a late adverse event (after the first 3-month period of treatment).
Martínez-García, MÁ Spain 2020^Citation67	Multi-center study of historic cohorts.	To identify the efficacy and safety of treatment with inhaled antibiotics in a dry powder formulation. To identify the patient profile most susceptible to adverse effects and withdrawal of the treatment.	Patients with bronchiectasis who had received at least one dose in a dry powder formulation. There were no criteria for exclusion due to the intention to perform a real-life study.	164 patients from 33 centers: 86% were treated with colistin and 14% with tobramycin. Women: 53% Age: 65.7 ± 14.4 years.	Dose: NS Duration: 6 ± 6.5 months (1–30).	After initiation of colistin, there was a significant reduction in: The number of non-severe and severe exacerbations. Percentage of patients with CBI due to P. aeruginosa (81% vs 52%) and other PPM (29% vs 10%). No differences were found in sputum production, dyspnea severity. or lung function impairment. There were no statistically significant differences between the efficacy of colistin and tobramycin.	At least one adverse effect was observed in 54.2% of the patients, and 24.4% had to interrupt their treatment as a result of an adverse effect (cough in 84% of these cases). These patients had more severe bronchiectasis, more time of symptoms, previous coughing, more difficulty in handling the device, and less therapeutic education about use of the device. Patients with colistin presented a lower proportion of withdrawals from treatment, less difficulty in using the device, and a smaller proportion of resistances to P. aeruginosa than patients under tobramycin treatment.
de la Rosa-Carrillo, D Spain 2021^Citation64	Multicenter, retrospective cohort study.	To describe the effectiveness and safety of inhaled antibiotics in COPD patients, as well as the patient profile in which they are usually prescribed and the patient groups that can most benefit from this treatment.	COPD patients who had received at least one dose of any inhaled antibiotic treatment in the five years prior to their inclusion in the study (2013–2018), and for whom exacerbation data were available for at least 1 year.	693 patients from 35 centers (73.9% of them had bronchiectasis). Different treatments: colistin (82.5%), tobramycin (15.3%), ceftazidime (1.6%), gentamicin (0.4%), or amikacin (0.1%). Women: 13.7% Age: 74.1 ± 8.5 years.	Dose: NS Median treatment duration: 8.9 months (0.1–71.5).	After initiation of inhaled antibiotics, there was a significant reduction in: Number of exacerbations (−33.3%), hospital admissions (−33.3%), and hospitalization days (−26.2%). Frequency and purulence of expectoration. Isolation of any PPM. CBI by any PPM. - CBI by PA.	25.4% of patients presented non-severe side effects, the most frequent of these being bronchospasm (10.5%), dyspnea (8.8%), and cough (1.7%).

Abbreviations: CBI, chronic bronchial infection; CF, cystic fibrosis; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; HR, hazard ratio; IV, intravenous; MU, mega units; NS, not specified; PPM, potentially pathogenic microorganism; RR, relative risk.

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