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An 8 week open-label interventional multicenter study to explore the lung clearance index as endpoint for clinical trials in cystic fibrosis patients ≥8 years of age, chronically infected with Pseudomonas aeruginosa

Crossref DOI link: https://doi.org/10.1186/s12890-020-01201-y

Published Online: 2020-06-12

Published Print: 2020-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Sutharsan, Sivagurunathan http://orcid.org/0000-0003-4069-4900
Naehrig, Susanne

Mellies, Uwe

Sieder, Christian

Ziegler, Jörg
Funding

Funding for this research was provided by:

Novartis Pharma (NA, NA)
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Article History

Received: 22 August 2019

Accepted: 28 May 2020

First Online: 12 June 2020

Ethics approval and consent to participate

: The study design was approved by the independent ethics committee and institutional review boards (InternalRef removed); and was in accordance with the Declaration of Helsinki. Informed consent was obtained from each patient (or from parents for children < 16 years of age) in writing before randomization.

: Not applicable.

: SS has served as an investigator in clinical trials for Galapagos, Proteostasis, Celtaxsys, Flatley, Novartis Pharma GmbH and Vertex Pharmaceuticals Incorporated and has consulted for Teva GmbH, Novartis Pharma GmbH, Chiesi GmbH and Vertex Pharmaceuticals Incorporated. SN and UM have nothing to disclose. CS and JZ are employees of Novartis Pharma GmbH.

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