Evidence map›Paper›PMID 31451351›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2020

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

Diana Bilton, Tacjana Pressler, Isabelle Fajac, John Paul Clancy, Dorota Sands, Predrag Minic, Marco Cipolli, Ivanka Galeva, Amparo Solé, Alexandra L Quittner and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01315678 (Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01315678 phase3completednot on this map

Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

TypeinterventionalSponsorInsmed IncorporatedRan2012 to 2013Enrolled302ConditionsPseudomonas Aeruginosa InfectionArmsLiposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Trial
  3. Review
  4. Mapping the knowledge landscape ofFrontiers in cellular and infection microbiology · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Nanotechnology-Based Therapeutics for Airway Inflammatory Diseases.Clinical reviews in allergy & immunology · 2025
    Review
  12. Review
  13. Review
  14. The Impact ofPathogens (Basel, Switzerland) · 2023
    Article
  15. Review
  16. Review
  17. Anti-Microorganisms · 2023
    Review
  18. Review
  19. Article
  20. Drugs, Drugs, Drugs: Current Treatment Paradigms in Cystic Fibrosis Airway Infections.Journal of the Pediatric Infectious Diseases Society · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 11 institutions in 8 countries.

Diana BiltonRoyal Brompton Hospital, London, United Kingdom.
Tacjana PresslerRigshospitalet (Hospital), Copenhagen, Denmark.
Isabelle FajacAP-HP, Université Paris Descartes, Paris, France.
John Paul ClancyCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Dorota SandsCystic Fibrosis Department, Institute of Mother and Child, Warsaw, Poland.
Predrag MinicInstitute for Mother and Child Health Care, Department of Pulmonology, Medical School University of Belgrade, Serbia.
Marco CipolliAzienda Ospedaliera Universitaria Integrata, Verona, Italy.
Ivanka GalevaPediatric Clinic, Infants Department, Alexandrovska University Hospital, Sofia, Bulgaria.
Amparo SoléLung Transplant and Cystic Fibrosis Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain.
Alexandra L QuittnerUniversity of Miami, Coral Gables, FL, USA.
Keith LiuInsmed Incorporated, Bridgewater, NJ, USA.
John P McGinnisInsmed Incorporated, Bridgewater, NJ, USA.
Gina EagleInsmed Incorporated, Bridgewater, NJ, USA.
Renu GuptaInsmed Incorporated, Bridgewater, NJ, USA.
Michael W KonstanCase Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH, USA. Electronic address: Michael.Konstan@case.edu.
CLEAR-108 Study Group
Délégation Paris 5 · FRInsmed (United States) · USAlexandrovska Hospital · BGRoyal Brompton Hospital · GBAzienda Ospedaliera Universitaria Integrata Verona · ITCincinnati Children's Hospital Medical Center · USHospital Universitari i Politècnic La Fe · ESRigshospitalet · DKUniversity of Belgrade · RSRainbow Babies & Children's Hospital · USUniversity of Miami · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
NCATS NIH HHS UL1 TR002548
6 · The paper itself

Abstract

backgroundShortcomings 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.

methodsEligible patients with forced expiratory volume in 1 s (FEV

resultsThe study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV

conclusionsCyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.

Indexed as

Cystic FibrosisPseudomonas aeruginosaAdministration, InhalationAdultAmikacinAnti-Bacterial AgentsDose-Response Relationship, DrugFemaleHospitalizationHumansLiposomesMalePseudomonas InfectionsRespiratory Function TestsSputumSurveys and QuestionnairesAmikacinAnti-Bacterial AgentsLiposomesTobramycinALISAmikacin liposome inhalation suspensionCFQ-RCystic fibrosisLAILiposomal amikacin for inhalationPseudomonas aeruginosa

Identifiers

PMID31451351
PMCPMC9078215
OpenAlexW2969484628

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.