Introduction to Inpulsis Trials - Open Label Extension

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Inpulsis Trials sentence examples within Open Label Extension

Open Label Extension
10.1136/bmjresp-2018-000397

Methods Data from patients treated with ≥1 dose of nintedanib 150 mg two times per day or placebo in the 52-week TOMORROW trial and/or its open-label extension; the two 52-week INPULSIS trials and/or their open-label extension, INPULSIS-ON; and a Phase IIIb trial with a placebo-controlled period of ≥6 months followed by open-label nintedanib were pooled.

Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials

Open Label Extension
10.1016/j.rmed.2019.08.002

BACKGROUND We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON.

Outcomes following decline in forced vital capacity in patients with idiopathic pulmonary fibrosis: Results from the INPULSIS and INPULSIS-ON trials of nintedanib.

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An Overview of Inpulsis Trials

Inpulsis Trials
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What is/are Inpulsis Trials?

Inpulsis Trials - The INPULSIS trials evaluated the efficacy and safety of nintedanib versus placebo in 1066 IPF patients with a diffusing capacity of the lung for carbon monoxide (DLCO) of 30–79% of the predicted value [2]. [1] We investigated the cardiovascular safety of nintedanib using pooled data from the TOMORROW and INPULSIS trials. [2] In post hoc analyses of pooled data from the INPULSIS trials, the treatment effect of nintedanib versus placebo was not influenced by the presence of emphysema (yes versus no) or by FEV1/FVC ratio (≥0. [3]

open label extension

Methods Data from patients treated with ≥1 dose of nintedanib 150 mg two times per day or placebo in the 52-week TOMORROW trial and/or its open-label extension; the two 52-week INPULSIS trials and/or their open-label extension, INPULSIS-ON; and a Phase IIIb trial with a placebo-controlled period of ≥6 months followed by open-label nintedanib were pooled. [1] BACKGROUND We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON. [2]

growth factor receptor

Nintedanib, a small molecule receptor tyrosine kinase inhibitor (TKI) of platelet‐derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR), has been approved for IPF after phase III INPULSIS trials in 2014. [1]