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Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis

Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis
Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis
The INPULSIS™ trials will determine the efficacy of nintedanib in patients with IPF, including its impact on disease progression as defined by decline in FVC, acute exacerbations and health-related quality of life. In addition, they will characterise the adverse event profile of nintedanib in this patient population. Trial registration: Registered at ClinicalTrials.gov (identifiers: NCT01335464 and NCT01335477).
clinical trial, phase III, drug therapy, protein kinase inhibitor, protein tyrosine kinases
1023-1030
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Cottin, Vincent
e73bdd1a-00d4-4cd2-9a0b-a796c361ca84
Flaherty, Kevin R.
9d1edc7b-124b-43b3-8d54-85f7b54b67ee
Kolb, Martin
f7169cba-735d-4c03-b348-55f170d1b5dd
Inoue, Yoshikazu
deae4955-7f69-4fc2-a611-7f3fc07d09c4
Raghu, Ganesh
bf5d4a84-1eae-4e42-aac8-5fb9fb49d2ab
Taniguchi, Hiroyuki
2ccfac1c-e5a4-4ac9-9683-1825867f1a1d
Hansell, David M
6ffd4a69-9a48-4062-b0ca-c509faedede7
Nicholson, Andrew G.
96615ec5-6082-4999-b383-fca53d2f991b
Le Maulf, Florence
1b82bd53-2bc7-4a05-8116-a8091a030265
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Collard, Harold R.
6eee2ce5-3016-4c13-ac58-f30a77f7d141
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Cottin, Vincent
e73bdd1a-00d4-4cd2-9a0b-a796c361ca84
Flaherty, Kevin R.
9d1edc7b-124b-43b3-8d54-85f7b54b67ee
Kolb, Martin
f7169cba-735d-4c03-b348-55f170d1b5dd
Inoue, Yoshikazu
deae4955-7f69-4fc2-a611-7f3fc07d09c4
Raghu, Ganesh
bf5d4a84-1eae-4e42-aac8-5fb9fb49d2ab
Taniguchi, Hiroyuki
2ccfac1c-e5a4-4ac9-9683-1825867f1a1d
Hansell, David M
6ffd4a69-9a48-4062-b0ca-c509faedede7
Nicholson, Andrew G.
96615ec5-6082-4999-b383-fca53d2f991b
Le Maulf, Florence
1b82bd53-2bc7-4a05-8116-a8091a030265
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Collard, Harold R.
6eee2ce5-3016-4c13-ac58-f30a77f7d141

Richeldi, Luca, Cottin, Vincent, Flaherty, Kevin R., Kolb, Martin, Inoue, Yoshikazu, Raghu, Ganesh, Taniguchi, Hiroyuki, Hansell, David M, Nicholson, Andrew G., Le Maulf, Florence, Stowasser, Susanne and Collard, Harold R. (2014) Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respiratory Medicine, 108 (7), 1023-1030. (doi:10.1016/j.rmed.2014.04.011). (PMID:24834811)

Record type: Article

Abstract

The INPULSIS™ trials will determine the efficacy of nintedanib in patients with IPF, including its impact on disease progression as defined by decline in FVC, acute exacerbations and health-related quality of life. In addition, they will characterise the adverse event profile of nintedanib in this patient population. Trial registration: Registered at ClinicalTrials.gov (identifiers: NCT01335464 and NCT01335477).

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More information

Published date: July 2014
Keywords: clinical trial, phase III, drug therapy, protein kinase inhibitor, protein tyrosine kinases
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 369050
URI: https://eprints.soton.ac.uk/id/eprint/369050
PURE UUID: ac68f824-a180-4524-a192-dc1415599abe

Catalogue record

Date deposited: 18 Sep 2014 14:32
Last modified: 18 Jul 2017 01:40

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Contributors

Author: Luca Richeldi
Author: Vincent Cottin
Author: Kevin R. Flaherty
Author: Martin Kolb
Author: Yoshikazu Inoue
Author: Ganesh Raghu
Author: Hiroyuki Taniguchi
Author: David M Hansell
Author: Andrew G. Nicholson
Author: Florence Le Maulf
Author: Susanne Stowasser
Author: Harold R. Collard

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