Study Design of a Phase III, Randomized, Placebo-Controlled Trial of Nintedanib in Children and Adolescents with Clinically Significant Fibrosing Interstitial Lung Disease (ILD)

被引：0
|
作者：
Young, L. [1 ]
Brown, K. K. [2 ]
Griese, M. [3 ]
Deutsch, G. [4 ]
Warburton, D. [5 ]
DeBoer, E. [6 ]
Cunningham, S. [7 ]
Clement, A. F. [8 ]
Schwerk, N. [9 ]
Flaherty, K. R. [10 ]
Voss, F. [11 ]
Schmid, U. [11 ]
Schlenker-Herceg, R. [12 ]
Verri, D. [13 ]
Stowasser, S. [14 ]
Clerisme-Beaty, E. M. [14 ]
Deterding, R. R. [6 ]
机构：
[1] Childrens Hosp Philadelphia, Div Pulm Med, Philadelphia, PA 19104 USA
[2] Natl Jewish Hlth, Denver, CO USA
[3] Ludwig Maximilians Univ Munchen, Hauner Childrens Hosp, Munich, Germany
[4] Univ Washington, Sch Med, Dept Pathol, Seattle, WA 98195 USA
[5] Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA
[6] Univ Colorado Denver, Sect Pediat Pulm & Sleep Med, Dept Pediat, Aurora, CO USA
[7] Univ Edinburgh, Ctr Inflammat Res, Edinburgh, Midlothian, Scotland
[8] Sorbonne Univ, Trousseau Hosp, AP HP, Pediat Pulm Dept, Paris, France
[9] Hannover Med Sch, Clin Pediat Pulmonol Allergol & Neonatol, Hannover, Germany
[10] Univ Michigan, Div Pulm & Crit Care Med, Ann Arbor, MI 48109 USA
[11] Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
[12] Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA
[13] Boehringer Ingelheim Italia SpA, Milan, Italy
[14] Boehringer Ingelheim Int GmbH, Ingelheim, Germany
来源：
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE | 2020年 / 201卷
关键词：
D O I：
暂无
中图分类号：
R4 [临床医学];
学科分类号：
1002 ; 100602 ;
摘要：
A1495
引用
收藏
页数：2
相关论文
共 50 条
  • [31] Fluoxetine for acute treatment of depression in children and adolescents: A placebo-controlled, randomized clinical trial
    Emslie, GJ
    Heiligenstein, JH
    Hoog, SL
    Judge, R
    Brown, E
    Nilsson, M
    BIOLOGICAL PSYCHIATRY, 2001, 49 (08) : 158S - 158S
  • [32] Fluoxetine for acute treatment of depression in children and adolescents: A placebo-controlled, randomized clinical trial
    Emslie, GJ
    Heiligenstein, JH
    Wagner, KD
    Hoog, SL
    Ernest, DE
    Brown, E
    Nilsson, M
    Jacobson, JG
    JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY, 2002, 41 (10): : 1205 - 1215
  • [33] A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression
    Emslie, GJ
    Rush, AJ
    Weinberg, WA
    Kowatch, RA
    Hughes, CW
    Carmody, T
    Rintelmann, J
    ARCHIVES OF GENERAL PSYCHIATRY, 1997, 54 (11) : 1031 - 1037
  • [34] Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial
    Roufosse, Florence
    Kahn, Jean-Emmanuel
    Rothenberg, Marc E.
    Wardlaw, Andrew J.
    Klion, Amy D.
    Kirby, Suyong Yun
    Gilson, Martyn J.
    Bentley, Jane H.
    Bradford, Eric S.
    Yancey, Steven W.
    Steinfeld, Jonathan
    Gleich, Gerald J.
    JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2020, 146 (06) : 1397 - 1405
  • [35] Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial
    Ikeda, Manabu
    Mori, Etsuro
    Matsuo, Kazutaka
    Nakagawa, Masaki
    Kosaka, Kenji
    ALZHEIMERS RESEARCH & THERAPY, 2015, 7
  • [36] Masitinib in nonresectable pancreatic cancer: Results of a phase III randomized placebo-controlled trial
    Deplanque, Gael
    Demarchi, Martin
    Hebbar, Mohamed
    Flynn, Patrick J.
    Melichar, Bohuslav
    Atkins, James
    Ruszniewski, Philippe
    Raymond, Eric
    Hermine, Olivier
    Hammel, Pascal
    JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (04)
  • [37] Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial
    Manabu Ikeda
    Etsuro Mori
    Kazutaka Matsuo
    Masaki Nakagawa
    Kenji Kosaka
    Alzheimer's Research & Therapy, 7
  • [38] A Randomized Double-Blind Placebo-Controlled Phase III Trial of Selegiline Monotherapy for Early Parkinson Disease
    Mizuno, Yoshikuni
    Hattori, Nobutaka
    Kondo, Tomoyoshi
    Nomoto, Masahiro
    Origasa, Hideki
    Takahashi, Ryosuke
    Yamamoto, Mitsutoshi
    Yanagisawa, Nobuo
    CLINICAL NEUROPHARMACOLOGY, 2017, 40 (05) : 201 - 207
  • [39] Estimating the effect of nintedanib on forced vital capacity in children and adolescents with fibrosing interstitial lung disease using a Bayesian dynamic borrowing approach
    Maher, Toby M.
    Brown, Kevin K.
    Cunningham, Steven
    DeBoer, Emily M.
    Deterding, Robin
    Fiorino, Elizabeth K.
    Griese, Matthias
    Schwerk, Nicolaus
    Warburton, David
    Young, Lisa R.
    Gahlemann, Martina
    Voss, Florian
    Stock, Christian
    PEDIATRIC PULMONOLOGY, 2024, 59 (04) : 1038 - 1046
  • [40] Design of a Randomized, Placebo-Controlled, Phase 3 Trial of Tofersen Initiated in Clinically Presymptomatic SOD1 Variant Carriers: the ATLAS Study
    Benatar, Michael
    Wuu, Joanne
    Andersen, Peter M.
    Bucelli, Robert C.
    Andrews, Jinsy A.
    Otto, Markus
    Farahany, Nita A.
    Harrington, Elizabeth A.
    Chen, Weiping
    Mitchell, Adele A.
    Ferguson, Toby
    Chew, Sheena
    Gedney, Liz
    Oakley, Sue
    Heo, Jeong
    Chary, Sowmya
    Fanning, Laura
    Graham, Danielle
    Sun, Peng
    Liu, Yingying
    Wong, Janice
    Fradette, Stephanie
    NEUROTHERAPEUTICS, 2022, 19 (04) : 1248 - 1258
12345