Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies

Robert J. Kaner; Ednan K. Bajwa; Moustapha El-Amine; Eduard Gorina; Renu Gupta; Howard M. Lazarus; Tracy R. Luckhardt; Majd Mouded; Kaity Posada; Luca Richeldi; John Stauffer; Ahmet Tutuncu; Fernando J. Martinez

doi:10.1164/rccm.201903-0592PP

Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies

Robert J. Kaner, Ednan K. Bajwa, Moustapha El-Amine, Eduard Gorina, Renu Gupta, Howard M. Lazarus, Tracy R. Luckhardt, Majd Mouded, Kaity Posada, Luca Richeldi, John Stauffer, Ahmet Tutuncu, Fernando J. Martinez

Risultato della ricerca: Contributo in rivista › Articolo in rivista

3 Citazioni (Scopus)

Abstract

Idiopathic pulmonary ﬁbrosis (IPF) is a progressivediseasewithamediansurvivalof 3–5 years (1, 2). The approval of nintedanib and pirfenidone by regulatory agencies worldwide has dramatically altered the landscape for testing new drugs for IPF treatment. These drugs slowed the progression of the FVC decline observed in IPF cohorts in phase III randomized, double-blind, placebo-controlled trials (3, 4).

Lingua originale	English
pagine (da-a)	133-139
Numero di pagine	7
Rivista	American Journal of Respiratory and Critical Care Medicine
Volume	200
DOI	https://doi.org/10.1164/rccm.201903-0592PP
Stato di pubblicazione	Pubblicato - 2019

Keywords

Anti-Inflammatory Agents, Non-Steroidal
Clinical Trials as Topic
Drug Approval
Drug Development
Drug Interactions
Drug Therapy, Combination
Humans
Idiopathic Pulmonary Fibrosis
Indoles
Patient Outcome Assessment
Protein Kinase Inhibitors
Pyridones
Quality of Life
Standard of Care
Vital Capacity
Walk Test

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10.1164/rccm.201903-0592PP

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Kaner, R. J., Bajwa, E. K., El-Amine, M., Gorina, E., Gupta, R., Lazarus, H. M., Luckhardt, T. R., Mouded, M., Posada, K., Richeldi, L., Stauffer, J., Tutuncu, A., & Martinez, F. J. (2019). Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies. American Journal of Respiratory and Critical Care Medicine, 200, 133-139. https://doi.org/10.1164/rccm.201903-0592PP

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title = "Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies",

abstract = "Idiopathic pulmonary ﬁbrosis (IPF) is a progressivediseasewithamediansurvivalof 3–5 years (1, 2). The approval of nintedanib and pirfenidone by regulatory agencies worldwide has dramatically altered the landscape for testing new drugs for IPF treatment. These drugs slowed the progression of the FVC decline observed in IPF cohorts in phase III randomized, double-blind, placebo-controlled trials (3, 4).",

keywords = "Anti-Inflammatory Agents, Non-Steroidal, Clinical Trials as Topic, Drug Approval, Drug Development, Drug Interactions, Drug Therapy, Combination, Humans, Idiopathic Pulmonary Fibrosis, Indoles, Patient Outcome Assessment, Protein Kinase Inhibitors, Pyridones, Quality of Life, Standard of Care, Vital Capacity, Walk Test, Anti-Inflammatory Agents, Non-Steroidal, Clinical Trials as Topic, Drug Approval, Drug Development, Drug Interactions, Drug Therapy, Combination, Humans, Idiopathic Pulmonary Fibrosis, Indoles, Patient Outcome Assessment, Protein Kinase Inhibitors, Pyridones, Quality of Life, Standard of Care, Vital Capacity, Walk Test",

author = "Kaner, {Robert J.} and Bajwa, {Ednan K.} and Moustapha El-Amine and Eduard Gorina and Renu Gupta and Lazarus, {Howard M.} and Luckhardt, {Tracy R.} and Majd Mouded and Kaity Posada and Luca Richeldi and John Stauffer and Ahmet Tutuncu and Martinez, {Fernando J.}",

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doi = "10.1164/rccm.201903-0592PP",

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Kaner, RJ, Bajwa, EK, El-Amine, M, Gorina, E, Gupta, R, Lazarus, HM, Luckhardt, TR, Mouded, M, Posada, K, Richeldi, L, Stauffer, J, Tutuncu, A & Martinez, FJ 2019, 'Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies', American Journal of Respiratory and Critical Care Medicine, vol. 200, pagg. 133-139. https://doi.org/10.1164/rccm.201903-0592PP

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AU - Kaner, Robert J.

AU - Bajwa, Ednan K.

AU - El-Amine, Moustapha

AU - Gorina, Eduard

AU - Gupta, Renu

AU - Lazarus, Howard M.

AU - Luckhardt, Tracy R.

AU - Mouded, Majd

AU - Posada, Kaity

AU - Richeldi, Luca

AU - Stauffer, John

AU - Tutuncu, Ahmet

AU - Martinez, Fernando J.

PY - 2019

Y1 - 2019

N2 - Idiopathic pulmonary ﬁbrosis (IPF) is a progressivediseasewithamediansurvivalof 3–5 years (1, 2). The approval of nintedanib and pirfenidone by regulatory agencies worldwide has dramatically altered the landscape for testing new drugs for IPF treatment. These drugs slowed the progression of the FVC decline observed in IPF cohorts in phase III randomized, double-blind, placebo-controlled trials (3, 4).

AB - Idiopathic pulmonary ﬁbrosis (IPF) is a progressivediseasewithamediansurvivalof 3–5 years (1, 2). The approval of nintedanib and pirfenidone by regulatory agencies worldwide has dramatically altered the landscape for testing new drugs for IPF treatment. These drugs slowed the progression of the FVC decline observed in IPF cohorts in phase III randomized, double-blind, placebo-controlled trials (3, 4).

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KW - Clinical Trials as Topic

KW - Drug Approval

KW - Drug Development

KW - Drug Interactions

KW - Drug Therapy, Combination

KW - Humans

KW - Idiopathic Pulmonary Fibrosis

KW - Indoles

KW - Patient Outcome Assessment

KW - Protein Kinase Inhibitors

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KW - Drug Interactions

KW - Drug Therapy, Combination

KW - Humans

KW - Idiopathic Pulmonary Fibrosis

KW - Indoles

KW - Patient Outcome Assessment

KW - Protein Kinase Inhibitors

KW - Pyridones

KW - Quality of Life

KW - Standard of Care

KW - Vital Capacity

KW - Walk Test

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UR - https://www.atsjournals.org/doi/pdf/10.1164/rccm.201903-0592pp

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JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

ER -

Design of idiopathic pulmonary fibrosis clinical trials in the era of approved therapies

Abstract

Keywords

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