Chest
Original ResearchAddition of Inhaled Tobramycin to Ciprofloxacin for Acute Exacerbations of Pseudomonas aeruginosa Infection in Adult Bronchiectasis
Section snippets
Design
A double-blind, randomized, active comparator, parallel-design study was conducted in 17 study centers (12 in the United States and 5 in the United Kingdom). Each center received Institutional Review Board or Ethics Committee approval prior to initiation. All subjects provided written informed consent before enrollment; confirmation of consent was obtained at the time of the exacerbation.
Population
Men and women between 18 and 80 years of age with bronchiectasis confirmed by the results of a central
Subject Demographics
Of 138 subjects screened, 53 were enrolled in the study, 26 were randomized to the TIS/Cip arm, and 27 were randomized to the placebo/Cip arm. Of those screened, 85 subjects were not randomized, 28 subjects either had no history of P aeruginosa infection or had no infection at screening, 24 subjects did not experience an exacerbation before the close of the study, 18 subjects had infection with Cip-resistant P aeruginosa, 4 subjects had no bronchiectasis on review of a high-resolution CT, 4
Discussion
This study represents the first randomized controlled trial of a nebulized antibiotic as adjunctive therapy for patients with an acute exacerbation of P aeruginosa infection in patients with non-CF bronchiectasis. In chronic airway infection with P aeruginosa in CF patients, clinical improvement is associated with a reduction in bacterial density rather than eradication.11 The few comparable studies performed in patients with non-CF bronchiectasis12, 13 have shown that successful treatment does
Participating Study Investigators
The authors present the data in the study on behalf of all the following participating investigators in this study: Wesley R. Bray, Marietta Pulmonary Medicine, Marietta, GA; Leslie Couch, University of Texas Health Center at Tyler, Tyler, TX; James D. DeMaio, Northwest Medical Specialties, Tacoma, WA; Graham Douglas, Aberdeen Royal Infirmary, Aberdeen, UK; Stuart Elborn, Belfast City Hospital, Belfast, Northern Ireland, UK; Gwen Huitt, National Jewish Medical & Research Center, Denver, CO;
ACKNOWLEDGMENT
The authors thank the following Chiron Corporation employees for their support: Uta Meyer, Xin Yu, and Kevin Hou for statistical analyses; Sally Anne Jones, Barbara Schaeffler, Alistair Leigh, Kara MacGowan, Stephen Shrewsbury, and Lyn Waring for clinical operations support; and Dutch VanDevanter, Jill Van Dalfsen, and Debbi Humble for data analyses and critical reading of this manuscript.
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2022, Respiratory MedicineCitation Excerpt :The investigators concluded that the long-term administration of inhaled antibiotics appears to affect the severity of illness, based on the number and days of hospitalisations, and that the therapy was safe [34]. Bilton and coworkers [35] conducted a multicentre, double-blind, randomised, active-comparator, parallel-design study that evaluated the effect of adding a 14-day course of TIS to oral ciprofloxacin in patients who presented with an acute exacerbation of bronchiectasis. All participants had bronchiectasis confirmed by results of a central reading of high-resolution CT scan of the chest, and chronic Pa infection with sputum culture positive for Pa within the 12 months before screening and at the time of screening (with sensitivity to ciprofloxacin at screening).
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2021, Respiratory MedicineCitation Excerpt :These results reflect the findings of the study by Orriols et al. (2015) (99.7% of the weight of the analysis), were the number of acute exacerbations, the frequency of hospital admissions due to exacerbations and the days of admission were significantly reduced compared to placebo at 15-months follow-up [7]. Two studies including 50 patients reported lung function measured by FEV1 in Liters [15,17]. Treatment with inhaled Tobramycin was not related to a significant difference in lung function compared to placebo (MD -0.20, 95% CI -0.54 to 0.14) (Fig. 8).
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
Chiron Corporation, manufacturers of Tobramycin Inhalation Solution (TOBI), sponsored this clinical study, and conducted data management and statistical analyses. Drs. Bilton and Gotfried have acted in the past as clinical consultants for Chiron Corporation. The authors did not receive compensation for either their participation as investigators in this study or for the writing of this article.
Manuscript received September 19, 2005; revision accepted May 4, 2005.