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Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa.
Ann Pharmacother. 2005 Jan; 39(1):39-44.AP

Abstract

BACKGROUND

Non-cystic fibrosis (CF) patients with bronchiectasis usually develop chronic bronchial infection with Pseudomonas aeruginosa (PA) that is related to worsening lung function and increased morbidity and mortality.

OBJECTIVE

To determine whether direct aerosol delivery of tobramycin to the lower airways may control infection and produce only low systemic toxicity.

METHODS

A double-blind, placebo-controlled crossover trial involving 30 patients was conducted to determine the clinical effectiveness and safety of 6-month tobramycin inhalation therapy. Patients received 300 mg of aerosolized tobramycin or placebo twice daily in 2 cycles, each for 6 months, with a one-month washout period. The number of exacerbations, number of hospital admissions, number of hospital admission days, antibiotic use, pulmonary function, quality of life, tobramycin toxicity, density of PA in sputum, emergence of bacterial resistance, and emergence of other opportunistic bacteria were recorded.

RESULTS

The number of admissions and days of admission (mean +/- SD) during the tobramycin period (0.15 +/- 0.37 and 2.05 +/- 5.03) were lower than those during the placebo period (0.75 +/-1.16 and 12.65 +/- 21.8) (p < 0.047). A decrease in PA density in sputum was associated with tobramycin administration in the analysis of the first 6-month cycle (p = 0.038). No significant differences were observed in the number of exacerbations, antibiotic use, pulmonary function, and quality of life. The emergence of bacterial resistance and other bacteria did not differ between the 2 periods of study. Inhaled tobramycin was associated with bronchospasm in 3 patients, but not with detectable ototoxicity or nephrotoxicity.

CONCLUSIONS

Aerosol administration of high-dose tobramycin in non-CF bronchiectatic patients for endobronchial infection with PA appears to be safe and decreases the risk of hospitalization and PA density in sputum. Nevertheless, pulmonary function and quality of life are not improved, and the risk of bronchospasm is appreciable.

Authors+Show Affiliations

Pneumology Service, Department of Medicine, Hospital Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15562142

Citation

Drobnic, M Estrella, et al. "Inhaled Tobramycin in Non-cystic Fibrosis Patients With Bronchiectasis and Chronic Bronchial Infection With Pseudomonas Aeruginosa." The Annals of Pharmacotherapy, vol. 39, no. 1, 2005, pp. 39-44.
Drobnic ME, Suñé P, Montoro JB, et al. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. Ann Pharmacother. 2005;39(1):39-44.
Drobnic, M. E., Suñé, P., Montoro, J. B., Ferrer, A., & Orriols, R. (2005). Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. The Annals of Pharmacotherapy, 39(1), 39-44.
Drobnic ME, et al. Inhaled Tobramycin in Non-cystic Fibrosis Patients With Bronchiectasis and Chronic Bronchial Infection With Pseudomonas Aeruginosa. Ann Pharmacother. 2005;39(1):39-44. PubMed PMID: 15562142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. AU - Drobnic,M Estrella, AU - Suñé,Pilar, AU - Montoro,J Bruno, AU - Ferrer,Adelaida, AU - Orriols,Ramon, Y1 - 2004/11/23/ PY - 2004/11/25/pubmed PY - 2005/3/30/medline PY - 2004/11/25/entrez SP - 39 EP - 44 JF - The Annals of pharmacotherapy JO - Ann Pharmacother VL - 39 IS - 1 N2 - BACKGROUND: Non-cystic fibrosis (CF) patients with bronchiectasis usually develop chronic bronchial infection with Pseudomonas aeruginosa (PA) that is related to worsening lung function and increased morbidity and mortality. OBJECTIVE: To determine whether direct aerosol delivery of tobramycin to the lower airways may control infection and produce only low systemic toxicity. METHODS: A double-blind, placebo-controlled crossover trial involving 30 patients was conducted to determine the clinical effectiveness and safety of 6-month tobramycin inhalation therapy. Patients received 300 mg of aerosolized tobramycin or placebo twice daily in 2 cycles, each for 6 months, with a one-month washout period. The number of exacerbations, number of hospital admissions, number of hospital admission days, antibiotic use, pulmonary function, quality of life, tobramycin toxicity, density of PA in sputum, emergence of bacterial resistance, and emergence of other opportunistic bacteria were recorded. RESULTS: The number of admissions and days of admission (mean +/- SD) during the tobramycin period (0.15 +/- 0.37 and 2.05 +/- 5.03) were lower than those during the placebo period (0.75 +/-1.16 and 12.65 +/- 21.8) (p < 0.047). A decrease in PA density in sputum was associated with tobramycin administration in the analysis of the first 6-month cycle (p = 0.038). No significant differences were observed in the number of exacerbations, antibiotic use, pulmonary function, and quality of life. The emergence of bacterial resistance and other bacteria did not differ between the 2 periods of study. Inhaled tobramycin was associated with bronchospasm in 3 patients, but not with detectable ototoxicity or nephrotoxicity. CONCLUSIONS: Aerosol administration of high-dose tobramycin in non-CF bronchiectatic patients for endobronchial infection with PA appears to be safe and decreases the risk of hospitalization and PA density in sputum. Nevertheless, pulmonary function and quality of life are not improved, and the risk of bronchospasm is appreciable. SN - 1060-0280 UR - https://www.unboundmedicine.com/medline/citation/15562142/Inhaled_tobramycin_in_non_cystic_fibrosis_patients_with_bronchiectasis_and_chronic_bronchial_infection_with_Pseudomonas_aeruginosa_ L2 - https://journals.sagepub.com/doi/10.1345/aph.1E099?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -