Kaponi 2017.
Methods |
Aims: to evaluate the effect of inhaled tobramycin and colistin on eradication of P aeruginosa in patients with NCFB [Abstract] Design: randomised trial Total study duration: 3 months Number of study centres and locations: not reported Study setting: not reported Methods of recruitment: not reported Withdrawals: not reported Study start and end dates: not reported Analysis by intent‐to‐treat: not reported |
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Participants | 52 adults were randomised. Inclusion criteria: non‐CF bronchiectasis with > 10⁴ CFUs of P aeruginosa/mL in sputum culture. Exclusion criteria: not reported Mean age: 58.6 years; standard deviation: 15.2 (not reported per group) Gender: 33 women, 19 men (not reported per group) Bronchiectasis diagnosis: not reported Definition of acute exacerbation: not reported. Severity of condition: not reported Baseline lung function: not reported Smoking history: not reported Baseline imbalances: not reported |
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Interventions | All patients received ciprofloxacin 750 mg bid for 14 days before randomisation. Tobramycin (n = 17) Dose: 300 mg; delivery mode: inhalation using Pari LC Plus jet nebulizer; frequency: twice daily; duration: 3 months Colistin (n = 18) Dose: 1 MU; delivery mode: inhalation using Pari LC Plus jet nebulizer; frequency: twice daily; duration: 3 months Saline solution (n = 17) Dose: 0.9% 4 mL; delivery mode: inhalation using Pari LC Plus jet nebulizer; frequency: twice daily; duration: 3 months |
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Outcomes | Sputum culture, volume and purulence, dyspnoea (MRC scale), spirometry, and SaO₂ were estimated before and after treatment | |
Notes |
Power calculation: not reported Trial registration: not reported Conflict of interest: not reported Funders: not reported Role of the sponsors: not reported Ethical approval: not reported Conclusions: "Our findings indicate that inhaled antibiotics, tobramycin and colistin may be effective in eradicating P aeruginosa, reducing bacterial load and improving symptoms of bronchiectatic patients. Further investigation is required". Significance values are given for improvements over 3 months, and both antibiotics are described as showing greater improvements compared to saline solution. Direct comparisons between the 2 antibiotics are not reported in this conference abstract. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Other bias | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |