Abstract | BACKGROUND: RESEARCH QUESTION: STUDY DESIGN AND METHODS: This was a phase 3, 16-week, multicenter, randomized, double-blind, placebo-controlled trial. Eligible adults with bronchiectasis were recruited from October 2018 to July 2021. On the basis of usual care, patients nebulized TIS (300 mg/5 mL twice daily) or normal saline (5 mL twice daily) via vibrating-mesh nebulizer. Treatment consisted of two cycles, each consisting of 28 days on-treatment and 28 days off-treatment. The coprimary end points included changes from baseline in P aeruginosa density and Quality-of-Life Bronchiectasis Respiratory Symptoms score on day 29. RESULTS: The modified intention-to-treat population consisted of 167 patients in the tobramycin group and 172 patients in the placebo group. Compared with placebo, TIS resulted in a significantly greater reduction in P aeruginosa density (adjusted mean difference, 1.74 log10 colony-forming units/g; 95% CI, 1.12-2.35; P < .001) and greater improvement in Quality-of-Life Bronchiectasis Respiratory Symptoms score (adjusted mean difference, 7.91; 95% CI, 5.72-10.11; P < .001) on day 29. Similar findings were observed on day 85. TIS resulted in a significant reduction in 24-h sputum volume and sputum purulence score on days 29, 57, and 85. More patients became culture negative for P aeruginosa in the tobramycin group than in the placebo group on day 29 (29.3% vs 10.6%). The incidence of adverse events and serious adverse events were comparable between the two groups. INTERPRETATION: TIS is an effective treatment option and has an acceptable safety profile in patients with bronchiectasis with P aeruginosa infection. TRIAL REGISTRATION: ClinicalTrials.gov; No. NCT03715322; URL: www. CLINICALTRIALS: gov.
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Authors | Wei-Jie Guan, Jin-Fu Xu, Hong Luo, Xing-Xiang Xu, Yuan-Lin Song, Wan-Li Ma, Zong-An Liang, Xue-Dong Liu, Guo-Jun Zhang, Xiao-Ju Zhang, Rong-Kai Li, Shu-Yang Zhu, Yi-Jie Zhang, Xing-Jun Cai, Li-Ping Wei, Dong-Bo Tian, Hui Zhao, Ping-Yan Chen, Jie-Ming Qu, Nan-Shan Zhong, TORNASOL Study Group |
Journal | Chest
(Chest)
Vol. 163
Issue 1
Pg. 64-76
(01 2023)
ISSN: 1931-3543 [Electronic] United States |
PMID | 35863486
(Publication Type: Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2022 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Tobramycin
- Anti-Bacterial Agents
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Topics |
- Humans
- Adult
- Tobramycin
- Pseudomonas Infections
(complications, drug therapy)
- Anti-Bacterial Agents
(therapeutic use)
- Quality of Life
- Administration, Inhalation
- Bronchiectasis
(complications, drug therapy)
- Double-Blind Method
- Pseudomonas aeruginosa
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