Skip to main content

Main menu

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • For authors
    • Instructions for authors
    • Submit a manuscript
    • Author FAQs
    • Open access
    • COVID-19 submission information
  • Alerts
  • Podcasts
  • Subscriptions
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

User menu

  • Log in
  • Subscribe
  • Contact Us
  • My Cart

Search

  • Advanced search
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

Login

European Respiratory Society

Advanced Search

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • For authors
    • Instructions for authors
    • Submit a manuscript
    • Author FAQs
    • Open access
    • COVID-19 submission information
  • Alerts
  • Podcasts
  • Subscriptions

Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study

Michael R. Loebinger, Eva Polverino, James D. Chalmers, Harm A.W.M. Tiddens, Herman Goossens, Michael Tunney, Felix C. Ringshausen, Adam T. Hill, Rashidkhan Pathan, Gerhild Angyalosi, Francesco Blasi, Stuart J. Elborn, Charles S. Haworth on behalf of the iBEST-1 Trial Team
European Respiratory Journal 2021 57: 2001451; DOI: 10.1183/13993003.01451-2020
Michael R. Loebinger
1Host Defence Unit, Royal Brompton Hospital and Harefield NHS Foundation Trust, London, UK
2Imperial College London, London, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: M.Loebinger@rbht.nhs.uk
Eva Polverino
3Respiratory Disease Department, Vall d’ Hebron University Hospital – VHIR, Barcelona, Spain
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James D. Chalmers
4Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Harm A.W.M. Tiddens
5Dept of Paediatric Pulmonology and Allergology, Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, The Netherlands
6Dept of Radiology and Nuclear Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Herman Goossens
7Dept of Clinical Microbiology, University Hospital Antwerp, Antwerp, Belgium
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Tunney
8Halo Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Felix C. Ringshausen
9Dept of Respiratory Medicine, Hannover Medical School, and Biomedical Research in End-stage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Felix C. Ringshausen
Adam T. Hill
10Dept of Respiratory Medicine, Royal Infirmary of Edinburgh, and University of Edinburgh, Edinburgh, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rashidkhan Pathan
11Novartis Healthcare Private Limited, Hyderabad, India
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gerhild Angyalosi
12Novartis Pharma AG, Basel, Switzerland
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Francesco Blasi
13Internal Medicine Dept, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy
14Dept of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Francesco Blasi
Stuart J. Elborn
2Imperial College London, London, UK
15Halo Research Group, Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK
16Imperial College and Royal Brompton Hospital and Harefield NHS Foundation Trust, London, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Charles S. Haworth
17Cambridge Centre for Lung Infection, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK
18Dept of Medicine, University of Cambridge, Cambridge, UK
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Abstract

The study aimed to determine the efficacy of a safe and well-tolerated dose and regimen of tobramycin inhalation powder (TIP) on Pseudomonas aeruginosa sputum density in patients with bronchiectasis.

This is a phase II, double-blind, randomised study in bronchiectasis patients aged ≥18 years with chronic P. aeruginosa infection. Patients were randomised 1:1:1 to either cohort A: three capsules of TIP once daily (84 mg); cohort B: five capsules once daily (140 mg) or cohort C: four capsules twice daily (224 mg). Within each cohort, patients were further randomised 2:2:1 either to TIP continuously, TIP cyclically (alternating 28 days of TIP and placebo) or placebo for 16 weeks, respectively and were followed up for 8 weeks.

Overall, 107 patients were randomised to cohorts A (n=34), B (n=36) and C (n=37). All three TIP doses significantly reduced the P. aeruginosa sputum density from baseline to day 29 versus placebo in a dose-dependent manner (p≤0.0001, each). A smaller proportion of patients in the continuous-TIP (34.1%) and cyclical-TIP (35.7%) groups experienced pulmonary exacerbations versus placebo (47.6%) and also required fewer anti-pseudomonal antibiotics (38.6% on continuous TIP and 42.9% on cyclical TIP) versus placebo (57.1%) although not statistically significant. Pulmonary exacerbation of bronchiectasis was the most frequent (37.4%) adverse event. Overall, TIP was well tolerated, however, 23.4% of the patients discontinued the study drug due to adverse events.

Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the P. aeruginosa sputum density in patients with bronchiectasis and chronic P. aeruginosa infection.

Abstract

Inhaled dry powder tobramycin (TOBI Podhaler) significantly reduced Pseudomonas aeruginosa sputum density and was well tolerated in patients with bronchiectasis https://bit.ly/3hsRQw9

Footnotes

  • This article has an editorial commentary: https://doi.org/10.1183/13993003.03390-2020

  • This article has supplementary material available from erj.ersjournals.com

  • This study is registered at www.ClinicalTrials.gov with identifier number NCT02712983.

  • Data sharing provision has not been made for this study.

  • Elements of the information presented in this publication were presented at the 2020 American Thoracic Society Conference.

  • Conflict of interest: E. Polverino reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and personal fees from Bayer, Menarini, Grifols, Zambon, Pfizer, Chiesi, Teva, Shire, Insmed and Polyphor, and grants from Chiesi and Grifols, outside the submitted work.

  • Conflict of interest: J.D. Chalmers reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and grants and personal fees from GSK, Boehringer-Ingelheim, AstraZeneca, Pfizer, Bayer Healthcare, Grifols, Napp, Aradigm corporation, and Insmed, outside the submitted work.

  • Conflict of interest: H.A.W.M. Tiddens reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and personal fees from Vertex and Gilead, grants and personal fees from Novartis, and grants from Roche, Vertex, Chiesi and Vectura, outside the submitted work.

  • Conflict of interest: H. Goossens reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study.

  • Conflict of interest: M. Tunney reports grants from European Union IMI grant in collaboration with Novartis, during the conduct of the study; and grants from European Union, Novartis and Alaxia SAS, outside the submitted work.

  • Conflict of interest: F.C. Ringhausen reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and grants, personal fees and non-financial support from Aposan, AstraZeneca, Bayer, Boehringer Ingelheim, Celtaxsys, Chiesi, Corbus, Grifols, InfectoPharm, Insmed, MSD, Novartis, PARI, Parion, Polyphor, Vertex and Zambon, outside the submitted work.

  • Conflict of interest: A.T. Hill reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study.

  • Conflict of interest: R. Pathan reports other from Novartis, outside the submitted work.

  • Conflict of interest: G. Angyalosi reports other from Novartis, outside the submitted work.

  • Conflict of interest: F. Blasi reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and grants and personal fees from AstraZeneca, Bayer, Grifols, Pfizer, Chiesi, GSK, Guidotti, Menarini, Novartis, Teva, Zambon and Insmed, outside the submitted work.

  • Conflict of interest: S.J. Elborn reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and grants from Novartis, and personal fees from Vertex, Galapagos and Ionis, outside the submitted work.

  • Conflict of interest: C.S. Haworth reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and grants and personal fees from Aradigm, Chiesi, Gilead, Grifols, GSK, Insmed, International Biophysics, Janssen, Mylan, Novartis, Teva, Vertex and Zambon, outside the submitted work.

  • Conflict of interest: M.R. Loebinger reports grants from European Union IMI Grant (in collaboration with Novartis), during the conduct of the study; and personal fees from Bayer, Grifols, Astra Zeneca, Insmed and Polyphor, outside the submitted work.

  • Support statement: This work has received support from the European Union/European Federation of Pharmaceutical Industries and Associations Innovative Medicines Initiative Joint Undertaking iABC grant agreement n°115721. The protocol was designed and conducted by Novartis in collaboration with the authors. Novartis was responsible for data collection, data analysis, data interpretation, and writing the article. All authors had full access to the entire study data and the corresponding author had the final responsibility for the decision to submit for publication. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Received April 28, 2020.
  • Accepted July 18, 2020.
  • Copyright ©ERS 2021
https://www.ersjournals.com/user-licence
View Full Text

ERS Members

myERS - ERS members : log in with your myERS username and password.

INDIVIDUALS

Log in Login as an individual user.

Forgot your username or password?

LIBRARY USERS

Log in through your institution

If your library has a subscription, you may already be logged in via your IP address. Otherwise you may be able to log in via one of the following routes.
You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.
If your organization uses OpenAthens, you can log in using your OpenAthens username and password. To check if your institution is supported, please see this list. Contact your library for more details.
If you think you should have access, please contact your librarian or email journals@ersnet.org

Purchase access

You may purchase access to this article. This will require you to create an account if you don't already have one.
PreviousNext
Back to top
View this article with LENS
Vol 57 Issue 1 Table of Contents
European Respiratory Journal: 57 (1)
  • Table of Contents
  • Index by author
Email

Thank you for your interest in spreading the word on European Respiratory Society .

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study
(Your Name) has sent you a message from European Respiratory Society
(Your Name) thought you would like to see the European Respiratory Society web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Print
Alerts
Sign In to Email Alerts with your Email Address
Citation Tools
Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study
Michael R. Loebinger, Eva Polverino, James D. Chalmers, Harm A.W.M. Tiddens, Herman Goossens, Michael Tunney, Felix C. Ringshausen, Adam T. Hill, Rashidkhan Pathan, Gerhild Angyalosi, Francesco Blasi, Stuart J. Elborn, Charles S. Haworth
European Respiratory Journal Jan 2021, 57 (1) 2001451; DOI: 10.1183/13993003.01451-2020

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

Share
Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study
Michael R. Loebinger, Eva Polverino, James D. Chalmers, Harm A.W.M. Tiddens, Herman Goossens, Michael Tunney, Felix C. Ringshausen, Adam T. Hill, Rashidkhan Pathan, Gerhild Angyalosi, Francesco Blasi, Stuart J. Elborn, Charles S. Haworth
European Respiratory Journal Jan 2021, 57 (1) 2001451; DOI: 10.1183/13993003.01451-2020
del.icio.us logo Digg logo Reddit logo Technorati logo Twitter logo CiteULike logo Connotea logo Facebook logo Google logo Mendeley logo
Full Text (PDF)

Jump To

  • Article
    • Abstract
    • Abstract
    • Introduction
    • Patients and methods
    • Results
    • Discussion
    • Supplementary material
    • Shareable PDF
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
  • Info & Metrics
  • PDF

Subjects

  • CF and non-CF bronchiectasis
  • Tweet Widget
  • Facebook Like
  • Google Plus One

More in this TOC Section

Original Articles

  • Maternal antibiotic use during pregnancy and asthma in children
  • Hyperglycaemia in cystic fibrosis adversely affects BK channel function
  • Validation of Lung EpiCheck for the detection of lung cancer
Show more Original Articles

Bronchiectasis

  • Sputum neutrophil elastase, microbiota and P. aeruginosa in bronchiectasis
  • ARD-3150 (inhaled liposomal ciprofloxacin) treatment in bronchiectasis
Show more Bronchiectasis

Related Articles

Navigate

  • Home
  • Current issue
  • Archive

About the ERJ

  • Journal information
  • Editorial board
  • Reviewers
  • CME
  • Press
  • Permissions and reprints
  • Advertising

The European Respiratory Society

  • Society home
  • myERS
  • Privacy policy
  • Accessibility

ERS publications

  • European Respiratory Journal
  • ERJ Open Research
  • European Respiratory Review
  • Breathe
  • ERS books online
  • ERS Bookshop

Help

  • Feedback

For authors

  • Instructions for authors
  • Submit a manuscript
  • ERS author centre

For readers

  • Alerts
  • Subjects
  • Podcasts
  • RSS

Subscriptions

  • Accessing the ERS publications

Contact us

European Respiratory Society
442 Glossop Road
Sheffield S10 2PX
United Kingdom
Tel: +44 114 2672860
Email: journals@ersnet.org

ISSN

Print ISSN:  0903-1936
Online ISSN: 1399-3003

Copyright © 2021 by the European Respiratory Society