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Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis

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Bilton, D, Pressler, T, Fajac, I, Clancy, JP, Sands, D, Minic, P, Cipolli, M, Galeva, I, Solé, A, Quittner, AL, Liu, K, McGinnis, JP, Eagle, G, Gupta, R, Konstan, MW & CLEAR-108 Study Group 2020, 'Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis' Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, bind 19, nr. 2, s. 284-291. https://doi.org/10.1016/j.jcf.2019.08.001

APA

CBE

Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Liu K, McGinnis JP, Eagle G, Gupta R, Konstan MW, CLEAR-108 Study Group. 2020. Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 19(2):284-291. https://doi.org/10.1016/j.jcf.2019.08.001

MLA

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Author

Bilton, Diana ; Pressler, Tacjana ; Fajac, Isabelle ; Clancy, John Paul ; Sands, Dorota ; Minic, Predrag ; Cipolli, Marco ; Galeva, Ivanka ; Solé, Amparo ; Quittner, Alexandra L ; Liu, Keith ; McGinnis, John P ; Eagle, Gina ; Gupta, Renu ; Konstan, Michael W ; CLEAR-108 Study Group. / Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. I: Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2020 ; Bind 19, Nr. 2. s. 284-291.

Bibtex

@article{1fafb732390d4f4f820e655492006801,
title = "Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis",
abstract = "BACKGROUND: Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung.METHODS: Eligible patients with forced expiratory volume in 1 s (FEV1) ≥25{\%} of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV1 (per-protocol population). Secondary endpoints included change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R).RESULTS: The study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95{\%} CI, -4.95 to 2.34) for relative change in FEV1 (L) from baseline. The mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms. Treatment-emergent adverse events (TEAEs) were reported in most patients (ALIS, 84.5{\%}; TIS, 78.8{\%}). Serious TEAEs occurred in 17.6{\%} and 19.9{\%} of patients, respectively; most were hospitalisations for infective pulmonary exacerbation of CF.CONCLUSIONS: Cyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.",
keywords = "ALIS, Amikacin liposome inhalation suspension, CFQ-R, Cystic fibrosis, LAI, Liposomal amikacin for inhalation, Pseudomonas aeruginosa",
author = "Diana Bilton and Tacjana Pressler and Isabelle Fajac and Clancy, {John Paul} and Dorota Sands and Predrag Minic and Marco Cipolli and Ivanka Galeva and Amparo Sol{\'e} and Quittner, {Alexandra L} and Keith Liu and McGinnis, {John P} and Gina Eagle and Renu Gupta and Konstan, {Michael W} and {CLEAR-108 Study Group}",
note = "Copyright {\circledC} 2019 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.",
year = "2020",
month = "3",
doi = "10.1016/j.jcf.2019.08.001",
language = "English",
volume = "19",
pages = "284--291",
journal = "Journal of Cystic Fibrosis",
issn = "1569-1993",
publisher = "Elsevier BV",
number = "2",

}

RIS

TY - JOUR

T1 - Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis

AU - Bilton, Diana

AU - Pressler, Tacjana

AU - Fajac, Isabelle

AU - Clancy, John Paul

AU - Sands, Dorota

AU - Minic, Predrag

AU - Cipolli, Marco

AU - Galeva, Ivanka

AU - Solé, Amparo

AU - Quittner, Alexandra L

AU - Liu, Keith

AU - McGinnis, John P

AU - Eagle, Gina

AU - Gupta, Renu

AU - Konstan, Michael W

AU - CLEAR-108 Study Group

N1 - Copyright © 2019 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

PY - 2020/3

Y1 - 2020/3

N2 - BACKGROUND: Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung.METHODS: Eligible patients with forced expiratory volume in 1 s (FEV1) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV1 (per-protocol population). Secondary endpoints included change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R).RESULTS: The study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV1 (L) from baseline. The mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms. Treatment-emergent adverse events (TEAEs) were reported in most patients (ALIS, 84.5%; TIS, 78.8%). Serious TEAEs occurred in 17.6% and 19.9% of patients, respectively; most were hospitalisations for infective pulmonary exacerbation of CF.CONCLUSIONS: Cyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.

AB - BACKGROUND: Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung.METHODS: Eligible patients with forced expiratory volume in 1 s (FEV1) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV1 (per-protocol population). Secondary endpoints included change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R).RESULTS: The study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV1 (L) from baseline. The mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms. Treatment-emergent adverse events (TEAEs) were reported in most patients (ALIS, 84.5%; TIS, 78.8%). Serious TEAEs occurred in 17.6% and 19.9% of patients, respectively; most were hospitalisations for infective pulmonary exacerbation of CF.CONCLUSIONS: Cyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.

KW - ALIS

KW - Amikacin liposome inhalation suspension

KW - CFQ-R

KW - Cystic fibrosis

KW - LAI

KW - Liposomal amikacin for inhalation

KW - Pseudomonas aeruginosa

U2 - 10.1016/j.jcf.2019.08.001

DO - 10.1016/j.jcf.2019.08.001

M3 - Journal article

VL - 19

SP - 284

EP - 291

JO - Journal of Cystic Fibrosis

JF - Journal of Cystic Fibrosis

SN - 1569-1993

IS - 2

ER -

ID: 59079610