Abstract

Introduction: ERS guidelines suggest the use of inhaled antibiotics in patients with bronchiectasis and chronic P. aeruginosa (PA) infection. However, none of them has been approved so far.

Aims and objectives: To evaluate the efficacy and safety of the tobramycin inhalation solution (TIS), Vantobra (Specialty Theurapeutics), in adult patients with bronchiectasis and PA in sputum.

Methods: We prospectively enroll clinically stable patients with bronchiectasis and PA in sputum (chronic infection or first isolation) followed up in our reference center. They receive off-label 170 mg TIS twice daily in three cycles (28 days on-off) via PARI eFlow rapid nebulizer. Clinical data, sputum culture, spirometry and Quality of life-Bronchiectasis (QOL-B) questionnaire are assessed at week 0, 5 and 24. Adverse events are recorded.

Results: Our study is ongoing and includes 13 patients so far. Nine patients completed treatment, three discontinued due to wheezing and one missed follow-up. Upon end of treatment,TIS significantly reduced PA sputum isolation (p=0.016) and a high rate of eradication was achieved (7/9, 78%). Moreover, TIS-treated patients showed after the first cycle a significant improvement in respiratory symptoms according to QOL-B (p=0.008). Similar results were observed in two additional aspects of QOL-B. TIS positive impact on quality of life was maintained at week 24. Common adverse events were transient voice hoarseness (three patients) and bronchiectasis exacerbation (one patient).

Conclusion: Our findings indicate that Vantobra may be effective in eradicating PA and improving quality of life of bronchiectasis patients with a good safety profile.