Inhaled colistimethate sodium in patients with bronchiectasis and Pseudomonas aeruginosa infection: results of PROMIS-I and PROMIS-II, two randomised, double-blind, placebo-controlled phase 3 trials assessing safety and efficacy over 12 months,The Lancet Respiratory Medicine

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Inhaled colistimethate sodium in patients with bronchiectasis and Pseudomonas aeruginosa infection: results of PROMIS-I and PROMIS-II, two randomised, double-blind, placebo-controlled phase 3 trials assessing safety and efficacy over 12 months
The Lancet Respiratory Medicine ( IF 38.7 ) Pub Date : 2024-09-10 , DOI: 10.1016/s2213-2600(24)00225-x
Charles S Haworth ₁ , Michal Shteinberg ₂ , Kevin Winthrop ₃ , Alan Barker ₄ , Francesco Blasi ₅ , Katerina Dimakou ₆ , Lucy C Morgan ₇ , Anne E O'Donnell ₈ , Felix C Ringshausen ₉ , Oriol Sibila ₁₀ , Rachel M Thomson ₁₁ , Kevin J Carroll ₁₂ , Federica Pontenani ₁₃ , Paola Castellani ₁₃ , James D Chalmers ₁₄ ,

Affiliation

Cambridge Centre for Lung Infection, Royal Papworth Hospital and University of Cambridge, Cambridge, UK.
Pulmonology Institute and CF Center, Carmel Medical Center, Haifa, Israel; Technion Israel Institute of Technology, the B Rappaport Faculty of Medicine, Haifa, Israel.
Division of Infectious Diseases, Oregon Health and Science University, Portland, OR, USA.
Department of Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR, USA.
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Respiratory Unit and Cystic Fibrosis Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
5th Respiratory Medicine Department, General Hospital for Chest Diseases of Athens Sotiria, Athens, Greece.
Department of Respiratory Medicine, Concord Repatriation General Hospital, Concord, NSW, Australia; University of Sydney, Sydney, NSW, Australia.
Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Medical Center, Washington, DC, USA.
Department of Respiratory Medicine and Infectious Diseases, Hannover Medical School, Hannover, Germany; Biomedical Research in Endstage and Obstructive Lung Disease Hannover, German Center of Lung Research, Hannover, Germany; European Reference Network on Rare and Complex Respiratory Diseases, Frankfurt, Germany.
Department of Respiratory Medicine, Hospital Clinic of Barcelona, University of Barcelona, Centro de Investigacion Biomedica En Red Enfermedades Respiratorias, Institut d Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Brisbane, QLD, Australia; University of Queensland, Brisbane, QLD, Australia.
KJC Statistics Ireland, Dublin, Ireland.
Research and Development Department. Zambon SpA, Bresso, Milan, Italy.
Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, UK.

Chronic lung infection with Pseudomonas aeruginosa is associated with increased exacerbations and mortality in people with bronchiectasis. The PROMIS-I and PROMIS-II trials investigated the efficacy and safety of 12-months of inhaled colistimethate sodium delivered via the I-neb.

中文翻译：

支气管扩张症和铜绿假单胞菌感染患者吸入性结肠胶酸钠：PROMIS-I 和 PROMIS-II 的结果，两项随机、双盲、安慰剂对照的 3 期试验，评估了 12 个月的安全性和有效性

铜绿假单胞菌慢性肺部感染与支气管扩张症患者的加重和死亡率增加有关。PROMIS-I 和 PROMIS-II 试验研究了通过 I-neb 给药 12 个月吸入 colistimethate 钠的疗效和安全性。

更新日期：2024-09-10

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