Evidence map›Paper›PMID 27748623›Full record

Trial reportAmerican journal of respiratory and critical care medicine2017

Randomized Trial of Liposomal Amikacin for Inhalation in Nontuberculous Mycobacterial Lung Disease.

Kenneth N Olivier, David E Griffith, Gina Eagle, John P McGinnis, Liza Micioni, Keith Liu, Charles L Daley, Kevin L Winthrop, Stephen Ruoss, Doreen J Addrizzo-Harris and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01315236 (A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease), which is not on this map. Cited by 97 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 8 pooled it
25.0field-weighted citation impact, top 1% 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.

NCT01315236 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease

TypeinterventionalSponsorInsmed IncorporatedRan2012 to 2015Enrolled90ConditionsMycobacterium Infections, NontuberculousArmsLiposomal amikacin for inhalation (LAI), placebo
3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 8 syntheses or guidelines pooled it, 243 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Guideline
  5. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Guideline
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Amikacin Liposome Inhalation Suspension forAnnals of the American Thoracic Society · 2021
    Trial
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Core outcome domains forERJ open research · 2025
    Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review

37 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 1 country.

Kenneth N Olivier1 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.ORCID 0000-0001-8200-255X
David E Griffith2 The University of Texas Health Science Center at Tyler, Tyler, Texas.
Gina Eagle3 Insmed Incorporated, Bridgewater, New Jersey.
John P McGinnis3 Insmed Incorporated, Bridgewater, New Jersey.
Liza Micioni3 Insmed Incorporated, Bridgewater, New Jersey.
Keith Liu3 Insmed Incorporated, Bridgewater, New Jersey.
Charles L Daley4 National Jewish Health, Denver, Colorado.
Kevin L Winthrop5 Oregon Health & Science University, Portland, Oregon.
Stephen Ruoss6 Stanford University School of Medicine, Stanford, California.
Doreen J Addrizzo-Harris7 New York University School of Medicine, New York, New York.
Patrick A Flume8 Medical University of South Carolina, Charleston, South Carolina.
Daniel Dorgan9 Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Matthias Salathe10 Leonard M. Miller School of Medicine, University of Miami, Miami, Florida; and.
Barbara A Brown-Elliott2 The University of Texas Health Science Center at Tyler, Tyler, Texas.
Renu Gupta3 Insmed Incorporated, Bridgewater, New Jersey.
Richard J Wallace2 The University of Texas Health Science Center at Tyler, Tyler, Texas.
Insmed (United States) · USThe University of Texas Health Science Center at Tyler · USMedical University of South Carolina · USNational Institutes of Health · USNational Jewish Health · USNew York University · USOregon Health & Science University · USStanford University · USUniversity of Miami · USUniversity of Pennsylvania · US

Funding

Bronchiectasis and chronic airway infectionZIAHL006200 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI FENNELLY, KEVIN · 2015 to 2025
$25.1M
6 · The paper itself

Abstract

rationaleLengthy, multidrug, toxic, and low-efficacy regimens limit management of pulmonary nontuberculous mycobacterial disease.

objectivesIn this phase II study, we investigated the efficacy and safety of liposomal amikacin for inhalation (LAI) in treatment-refractory pulmonary nontuberculous mycobacterial (Mycobacterium avium complex [MAC] or Mycobacterium abscessus) disease.

methodsDuring the double-blind phase, patients were randomly assigned to LAI (590 mg) or placebo once daily added to their multidrug regimen for 84 days. Both groups could receive open-label LAI for 84 additional days. The primary endpoint was change from baseline to Day 84 on a semiquantitative mycobacterial growth scale. Other endpoints included sputum conversion, 6-minute-walk distance, and adverse events. MEASUREMENTS AND MAIN

resultsThe modified intention-to-treat population included 89 (LAI = 44; placebo = 45) patients. The average age of the sample was 59 years; 88% were female; 92% were white; and 80 and 59 patients completed study drug dosing during the double-blind and open-label phases, respectively. The primary endpoint was not achieved (P = 0.072); however, a greater proportion of the LAI group demonstrated at least one negative sputum culture (14 [32%] of 44 vs. 4 [9%] of 45; P = 0.006) and improvement in 6-minute-walk test (+20.6 m vs. -25.0 m; P = 0.017) at Day 84. A treatment effect was seen predominantly in patients without cystic fibrosis with MAC and was sustained 1 year after LAI. Most adverse events were respiratory, and in some patients it led to drug discontinuation.

conclusionsAlthough the primary endpoint was not reached, LAI added to a multidrug regimen produced improvements in sputum conversion and 6-minute-walk distance versus placebo with limited systemic toxicity in patients with refractory MAC lung disease. Further research in this area is needed. Clinical trial registered with www.clinicaltrials.gov (NCT01315236).

Indexed as

Administration, InhalationAmikacinAnti-Bacterial AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedMycobacterium Infections, NontuberculousNontuberculous MycobacteriaProspective StudiesTreatment OutcomeAmikacinAnti-Bacterial Agentsculture conversionefficacynontuberculous mycobacteriasafety

Identifiers

PMID27748623
PMCPMC5363966
OpenAlexW2532369118

What OpenQuestion holds

Textmetadata
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.