A Randomized Controlled Trial of Nebulized Gentamicin in Non-Cystic Fibrosis Bronchiectasis

TY - JOUR

T1 - A Randomized Controlled Trial of Nebulized Gentamicin in Non-Cystic Fibrosis Bronchiectasis

AU - Murray, Maeve P.

AU - Govan, John R. W.

AU - Doherty, Catherine J.

AU - Simpson, A. John

AU - Wilkinson, Thomas S.

AU - Chalmers, James D.

AU - Greening, Andrew P.

AU - Haslett, Christopher

AU - Hill, Adam T.

PY - 2011/2/15

Y1 - 2011/2/15

N2 - Rationale: Bronchiectasis is a chronic debilitating disease with few evidence-based long-term treatments.Objectives: A randomized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis.Methods: Sixty-five patients were randomized to either twice-daily nebulized gentamicin, 80 mg, or nebulized 0.9% saline, for 12 months. All were reviewed at three-monthly intervals during treatment and at 3 months' follow-up.Measurements and Main Results: At each review the following were assessed: quantitative and qualitative sputum bacteriology; sputum purulence and 24-hour volume; FEV(1), FVC, and forced expiratory flow, midexpiratory phase; exercise capacity; Leicester Cough Questionnaire and St. George's Respiratory Questionnaire; and exacerbation frequency. Fifty-seven patients completed the study. At the end of 12 months' treatment, compared with the saline group, in the gentamicin group there was reduced sputum bacterial density with 30.8% eradication in those infected with Pseudomonas aeruginosa and 92.8% eradication in those infected with other pathogens; less sputum purulence (8.7% vs. 38.5%; P <0.0001); greater exercise capacity (510 [350-690] m vs. 415 [267.5-530] m; P=0.03); and fewer exacerbations (0 [0-1] vs. 1.5 [1-2]; PConclusions: Regular, long-term nebulized gentamicin is of significant benefit in non-cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy. Clinical trial registered with www.clinicaltrials.gov (NCT 00749866).

AB - Rationale: Bronchiectasis is a chronic debilitating disease with few evidence-based long-term treatments.Objectives: A randomized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis.Methods: Sixty-five patients were randomized to either twice-daily nebulized gentamicin, 80 mg, or nebulized 0.9% saline, for 12 months. All were reviewed at three-monthly intervals during treatment and at 3 months' follow-up.Measurements and Main Results: At each review the following were assessed: quantitative and qualitative sputum bacteriology; sputum purulence and 24-hour volume; FEV(1), FVC, and forced expiratory flow, midexpiratory phase; exercise capacity; Leicester Cough Questionnaire and St. George's Respiratory Questionnaire; and exacerbation frequency. Fifty-seven patients completed the study. At the end of 12 months' treatment, compared with the saline group, in the gentamicin group there was reduced sputum bacterial density with 30.8% eradication in those infected with Pseudomonas aeruginosa and 92.8% eradication in those infected with other pathogens; less sputum purulence (8.7% vs. 38.5%; P <0.0001); greater exercise capacity (510 [350-690] m vs. 415 [267.5-530] m; P=0.03); and fewer exacerbations (0 [0-1] vs. 1.5 [1-2]; PConclusions: Regular, long-term nebulized gentamicin is of significant benefit in non-cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy. Clinical trial registered with www.clinicaltrials.gov (NCT 00749866).

KW - QUALITY-OF-LIFE

KW - bronchiectasis

KW - CHRONIC BRONCHIAL INFECTION

KW - TOBRAMYCIN SOLUTION

KW - OBSTRUCTIVE PULMONARY-DISEASE

KW - ANTIBIOTIC-THERAPY

KW - gentamicin

KW - nebulized anibiotics

KW - HEALTH-STATUS

KW - ADULT BRONCHIECTASIS

KW - PSEUDOMONAS-AERUGINOSA

KW - LEICESTER COUGH QUESTIONNAIRE

KW - GEORGES RESPIRATORY QUESTIONNAIRE

U2 - 10.1164/rccm.201005-0756OC

DO - 10.1164/rccm.201005-0756OC

M3 - Article

C2 - 20870753

SN - 1073-449X

VL - 183

SP - 491

EP - 499

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

IS - 4

ER -