Evidence map›Paper›PMID 21075062›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2011

Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.

Michael W Konstan, Patrick A Flume, Matthias Kappler, Raphaël Chiron, Mark Higgins, Florian Brockhaus, Jie Zhang, Gerhild Angyalosi, Ellie He, David E Geller

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02102152 (Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection), which is not on this map. Cited by 109 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 7 pooled it
14.4field-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.

NCT02102152 naunknown statusnot on this mapstarted 2014, after this paper: background citation

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

TypeinterventionalSponsorRabin Medical CenterRan2014 to 2016Enrolled40ConditionsBronchiectasis With Chronic Infection With Pseudomonas AeruginosaArmsTobramycin
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 7 syntheses or guidelines pooled it, 312 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Systematic review of the dry powder inhalers colistimethate sodium and tobramycin in cystic fibrosis.European respiratory review : an official journal of the European Respiratory Society · 2013
    Pooled it
  8. Trial
  9. Trial
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  17. Article
  18. Review
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49 more citing papers are in PubMed but not listed here.

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

10 authors at 8 institutions in 5 countries.

Michael W KonstanRainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, USA. michael.konstan@UHhospitals.org
Patrick A Flume
Matthias Kappler
Raphaël Chiron
Mark Higgins
Florian Brockhaus
Jie Zhang
Gerhild Angyalosi
Ellie He
David E Geller
Novartis (Switzerland) · CHTris Pharma (United States) · USHôpital Arnaud de Villeneuve · FRLudwig-Maximilians-Universität München · DEMedical University of South Carolina · USNemours Children's Clinic · USNovartis (United Kingdom) · GBRainbow Babies & Children's Hospital · US

Funding

Translational Research in Cystic FibrosisP30DK027651 · NIDDK · CASE WESTERN RESERVE UNIVERSITY · PI DRUMM, MITCHELL L · 1986 to 2014
$15.6M
NIDDK NIH HHS P30 DK027651
6 · The paper itself

Abstract

backgroundA light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere® technology, to improve airway delivery efficiency, substantially reduce delivery time, and improve patient convenience and satisfaction. We evaluated the safety, efficacy and convenience of tobramycin inhalation powder (TIP™) versus tobramycin inhalation solution (TIS, TOBI®) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged ≥6 years.

methodsIn this open-label study, 553 patients were randomized 3:2 to TIP (total 112mg tobramycin) via the Novartis T-326 Inhaler or TIS 300mg/5mL via PARI LC® PLUS nebulizer twice daily for three treatment cycles (28 days on-drug, 28 days off-drug). Safety, efficacy, and treatment satisfaction outcomes were evaluated.

resultsTIP was generally well-tolerated; adverse events were similar in both groups. The rate of cough suspected to be study drug related was higher in TIP-treated patients (TIP: 25.3%; TIS: 4.3%), as was the overall discontinuation rate (TIP: 26.9%; TIS: 18.2%). Increases in FEV(1)% predicted from baseline to Day 28 of Cycle 3 were similar between groups; the mean reduction in sputum P. aeruginosa density (log(10) CFU/g) on Day 28 of Cycle 3 was also comparable between groups. Administration time was significantly less for TIP (mean: 5.6 versus 19.7min, p<0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction.

conclusionsTIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF.

Indexed as

Dry Powder InhalersTobramycinAdministration, InhalationAdolescentAdultAgedAnti-Bacterial AgentsChildCoughCystic FibrosisDrug Administration ScheduleDrug Delivery SystemsDrug MonitoringFemaleHumansMaleAnti-Bacterial AgentsPowdersTobramycin

Identifiers

PMID21075062
PMCPMC4086197
OpenAlexW2075069205

What OpenQuestion holds

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LicenceTDM
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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.