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The Capital Region of Denmark - a part of Copenhagen University Hospital
E-pub ahead of print

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

Research output: Contribution to journalJournal articleResearchpeer-review

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  • Diana Bilton
  • Tacjana Pressler
  • Isabelle Fajac
  • John Paul Clancy
  • Dorota Sands
  • Predrag Minic
  • Marco Cipolli
  • Ivanka Galeva
  • Amparo Solé
  • Alexandra L Quittner
  • Keith Liu
  • John P McGinnis
  • Gina Eagle
  • Renu Gupta
  • Michael W Konstan
  • CLEAR-108 Study Group
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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.

Original languageEnglish
JournalJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society
ISSN1569-1993
DOIs
Publication statusE-pub ahead of print - 2020

    Research areas

  • ALIS, Amikacin liposome inhalation suspension, CFQ-R, Cystic fibrosis, LAI, Liposomal amikacin for inhalation, Pseudomonas aeruginosa

ID: 59079610