Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis

Alan F. Barker, Leslie Couch, Stanley Fiel, Mark H. Gotfried, Jonathan Ilowite, Keith C. Meyer, Anne ODonnell, Steven A. Sahn, Lewis J. Smith, Jack O. Stewart, Tammy Abuan, Heather Tully, Jill Van Dalfsen, Charles D. Wells, Joanne Quan

Research output: Contribution to journalArticle

242 Citations (Scopus)

Abstract

We conducted a placebo-controlled, double-blind, randomized study to evaluate the microbiological efficacy and safety of inhaled tobramycin for treatment of patients with bronchiectasis and Pseudomonas aeruginosa. Patients were randomly assigned to receive either tobramycin solution for inhalation (TSI) (n = 37) or placebo (n = 37), which was self-administered twice daily for 4 wk and followed by 2-wk off-drug. At Week 4, the TSI group had a mean decrease in P. aeruginosa density of 4.54 log10 colony-forming units (cfu)/g sputum compared with no change in the placebo group (p < 0.01). At Week 6, P. aeruginosa was eradicated in 35% of TSI patients but was detected in all placebo patients. Investigators indicated that 62% of TSI patients showed an improved medical condition compared with 38% of placebo patients (odds ratio = 2.7, 95% confidence interval [Cl] 1.1 to 6.9). Tobramycin-resistant P. aeruginosa strains developed in 11% of TSI patients and 3% of placebo patients (p = 0.36). The mean percent change in FEV1 percent predicted from Week 0 to Week 4 was similar for the TSI and placebo groups (p = 0.41). More TSI-treated patients than placebo patients reported increased cough, dyspnea, wheezing, and noncardiac chest pain, but the symptoms did not limit therapy. Additional study is warranted to further evaluate TSI in bronchiectasis patients.

Original languageEnglish (US)
Pages (from-to)481-485
Number of pages5
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume162
Issue number2 I
DOIs
StatePublished - Jan 1 2000

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Tobramycin
Bronchiectasis
Sputum
Pseudomonas aeruginosa
Inhalation
Placebos
Respiratory Sounds
Chest Pain
Double-Blind Method
Cough
Dyspnea
Stem Cells
Odds Ratio
Research Personnel
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Cite this

Barker, Alan F. ; Couch, Leslie ; Fiel, Stanley ; Gotfried, Mark H. ; Ilowite, Jonathan ; Meyer, Keith C. ; ODonnell, Anne ; Sahn, Steven A. ; Smith, Lewis J. ; Stewart, Jack O. ; Abuan, Tammy ; Tully, Heather ; Van Dalfsen, Jill ; Wells, Charles D. ; Quan, Joanne. / Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. In: American Journal of Respiratory and Critical Care Medicine. 2000 ; Vol. 162, No. 2 I. pp. 481-485.
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abstract = "We conducted a placebo-controlled, double-blind, randomized study to evaluate the microbiological efficacy and safety of inhaled tobramycin for treatment of patients with bronchiectasis and Pseudomonas aeruginosa. Patients were randomly assigned to receive either tobramycin solution for inhalation (TSI) (n = 37) or placebo (n = 37), which was self-administered twice daily for 4 wk and followed by 2-wk off-drug. At Week 4, the TSI group had a mean decrease in P. aeruginosa density of 4.54 log10 colony-forming units (cfu)/g sputum compared with no change in the placebo group (p < 0.01). At Week 6, P. aeruginosa was eradicated in 35{\%} of TSI patients but was detected in all placebo patients. Investigators indicated that 62{\%} of TSI patients showed an improved medical condition compared with 38{\%} of placebo patients (odds ratio = 2.7, 95{\%} confidence interval [Cl] 1.1 to 6.9). Tobramycin-resistant P. aeruginosa strains developed in 11{\%} of TSI patients and 3{\%} of placebo patients (p = 0.36). The mean percent change in FEV1 percent predicted from Week 0 to Week 4 was similar for the TSI and placebo groups (p = 0.41). More TSI-treated patients than placebo patients reported increased cough, dyspnea, wheezing, and noncardiac chest pain, but the symptoms did not limit therapy. Additional study is warranted to further evaluate TSI in bronchiectasis patients.",
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Barker, AF, Couch, L, Fiel, S, Gotfried, MH, Ilowite, J, Meyer, KC, ODonnell, A, Sahn, SA, Smith, LJ, Stewart, JO, Abuan, T, Tully, H, Van Dalfsen, J, Wells, CD & Quan, J 2000, 'Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis', American Journal of Respiratory and Critical Care Medicine, vol. 162, no. 2 I, pp. 481-485. https://doi.org/10.1164/ajrccm.162.2.9910086

Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. / Barker, Alan F.; Couch, Leslie; Fiel, Stanley; Gotfried, Mark H.; Ilowite, Jonathan; Meyer, Keith C.; ODonnell, Anne; Sahn, Steven A.; Smith, Lewis J.; Stewart, Jack O.; Abuan, Tammy; Tully, Heather; Van Dalfsen, Jill; Wells, Charles D.; Quan, Joanne.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 162, No. 2 I, 01.01.2000, p. 481-485.

Research output: Contribution to journalArticle

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T1 - Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis

AU - Barker, Alan F.

AU - Couch, Leslie

AU - Fiel, Stanley

AU - Gotfried, Mark H.

AU - Ilowite, Jonathan

AU - Meyer, Keith C.

AU - ODonnell, Anne

AU - Sahn, Steven A.

AU - Smith, Lewis J.

AU - Stewart, Jack O.

AU - Abuan, Tammy

AU - Tully, Heather

AU - Van Dalfsen, Jill

AU - Wells, Charles D.

AU - Quan, Joanne

PY - 2000/1/1

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N2 - We conducted a placebo-controlled, double-blind, randomized study to evaluate the microbiological efficacy and safety of inhaled tobramycin for treatment of patients with bronchiectasis and Pseudomonas aeruginosa. Patients were randomly assigned to receive either tobramycin solution for inhalation (TSI) (n = 37) or placebo (n = 37), which was self-administered twice daily for 4 wk and followed by 2-wk off-drug. At Week 4, the TSI group had a mean decrease in P. aeruginosa density of 4.54 log10 colony-forming units (cfu)/g sputum compared with no change in the placebo group (p < 0.01). At Week 6, P. aeruginosa was eradicated in 35% of TSI patients but was detected in all placebo patients. Investigators indicated that 62% of TSI patients showed an improved medical condition compared with 38% of placebo patients (odds ratio = 2.7, 95% confidence interval [Cl] 1.1 to 6.9). Tobramycin-resistant P. aeruginosa strains developed in 11% of TSI patients and 3% of placebo patients (p = 0.36). The mean percent change in FEV1 percent predicted from Week 0 to Week 4 was similar for the TSI and placebo groups (p = 0.41). More TSI-treated patients than placebo patients reported increased cough, dyspnea, wheezing, and noncardiac chest pain, but the symptoms did not limit therapy. Additional study is warranted to further evaluate TSI in bronchiectasis patients.

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