scholarly journals Phase 2 clinical trial of PBI-4050 in patients with idiopathic pulmonary fibrosis

2018 ◽  
Vol 53 (3) ◽  
pp. 1800663 ◽  
Author(s):  
Nasreen Khalil ◽  
Helene Manganas ◽  
Christopher J. Ryerson ◽  
Shane Shapera ◽  
Andre M. Cantin ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Vital Capacity ◽  
Open Label ◽  
Open Label Study ◽  
Phase 2 Clinical Trial ◽  
Small Molecule Compound ◽  
The Stability ◽  
Oral Doses ◽  
Orally Active

PBI-4050 is a novel orally active small-molecule compound with demonstrated anti-fibrotic activity in several models of fibrosis, including lung fibrosis. We present results from our first clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF).This 12-week open-label study explored the safety, efficacy and pharmacokinetics of daily oral doses of 800 mg PBI-4050 alone and in combination with nintedanib or pirfenidone in patients with predominantly mild or moderate IPF. Nine patients received PBI-4050 alone, 16 patients received PBI-4050 with nintedanib and 16 patients received PBI-4050 with pirfenidone.PBI-4050 alone or in combination with nintedanib or pirfenidone was well tolerated. Pharmacokinetic profiles for PBI-4050 were similar in the PBI-4050 alone and PBI-4050+nintedanib groups but reduced in the PBI-4050+pirfenidone group, suggesting a drug–drug interaction. There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib. In contrast, a statistically significant reduction (p<0.024) in FVC % pred was seen for PBI-4050+pirfenidone after 12 weeks.There were no safety concerns with PBI-4050 alone or in combination with nintedanib or pirfenidone in IPF patients. The stability of FVC between baseline and week 12 looked encouraging for PBI-4050 alone and in combination with nintedanib.

scholarly journals Safety and tolerability of bosentan in idiopathic pulmonary fibrosis: an open label study

2007 ◽  
Vol 29 (4) ◽  
pp. 713-719 ◽  
Author(s):  
A. Gunther ◽  
B. Enke ◽  
P. Markart ◽  
P. Hammerl ◽  
H. Morr ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP)

Respiration ◽  
2017 ◽  
Vol 94 (5) ◽  
pp. 408-415 ◽  
Author(s):  
Ulrich Costabel ◽  
Carlo Albera ◽  
Lisa H. Lancaster ◽  
Chin-Yu Lin ◽  
Philip Hormel ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Analysis of patients with idiopathic pulmonary fibrosis (IPF) with percent predicted forced vital capacity (FVC) < 50% treated with pirfenidone in RECAP

Pneumologie ◽  
2017 ◽  
Vol 71 (S 01) ◽  
pp. S1-S125
Author(s):  
U Costabel ◽  
C Albera ◽  
KU Kirchgaessler ◽  
F Gilberg ◽  
U Petzinger ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Forced Vital Capacity ◽  
Vital Capacity

scholarly journals Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension

Thorax ◽  
2017 ◽  
Vol 73 (6) ◽  
pp. 581-583 ◽  
Author(s):  
Luca Richeldi ◽  
Michael Kreuter ◽  
Moisés Selman ◽  
Bruno Crestani ◽  
Anne-Marie Kirsten ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Term Treatment ◽  
Adverse Event Profile ◽  
Open Label ◽  
Comparator Group ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
Rate Of Decline

The TOMORROW trial of nintedanib comprised a randomised, placebo-controlled, 52-week period followed by a further blinded treatment period and an open-label extension. We assessed outcomes across these periods in patients randomised to nintedanib 150 mg twice daily or placebo at the start of TOMORROW. The annual rate of decline in FVC was −125.4 mL/year (95% CI −168.1 to −82.7) in the nintedanib group and −189.7 mL/year (95% CI −229.8 to −149.6) in the comparator group. The adverse event profile of nintedanib remained consistent throughout the studies. These results support a benefit of nintedanib on slowing progression of idiopathic pulmonary fibrosis beyond 52 weeks.

scholarly journals Coexistent emphysema delays the decrease of vital capacity in idiopathic pulmonary fibrosis

2009 ◽  
Vol 103 (8) ◽  
pp. 1209-1215 ◽  
Author(s):  
Takanori Akagi ◽  
Takemasa Matsumoto ◽  
Taishi Harada ◽  
Makoto Tanaka ◽  
Takashige Kuraki ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Vital Capacity

scholarly journals Efficacy of early antifibrotic treatment for idiopathic pulmonary fibrosis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keishi Sugino ◽  
Hirotaka Ono ◽  
Natsumi Watanabe ◽  
Masahiro Ando ◽  
Eiyasu Tsuboi ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Disease Progression ◽  
Vital Capacity ◽  
Early Stage ◽  
Japanese Patients ◽  
Oxygen Desaturation ◽  
Stage I ◽  
Relative Decline ◽  
Antifibrotic Drugs

Abstract Background Although antifibrotic drugs, including nintedanib and pirfenidone, slow the progression of idiopathic pulmonary fibrosis (IPF), there is little data about the timing of start of antifibrotic treatment in real-world clinical practice. The present study aimed to clarify the efficacy of nintedanib and pirfenidone in patients with early-stage IPF. Methods We compared survival and disease progression between patients with IPF with Japanese Respiratory Society (JRS) disease severity system stage I with and without oxygen desaturation on the 6-min walk test (6MWT) and increased the gender–age–physiology (GAP) staging. We examined the efficacy of antifibrotic drugs in patients with early-stage IPF. Results The severity of stage I IPF (n = 179) according to the JRS criteria consisted of the following GAP staging criteria: stage I, 111 cases; stage II, 58 cases; stage III, 10 cases. The duration from the initial visit to disease progression and survival time was significantly shorter in JRS stage I patients with oxygen desaturation on the 6MWT or with increased GAP staging (unfavorable group) compared with patients without those factors. In the unfavorable group, the relative decline in percentage predicted forced vital capacity (%FVC) over 6 months was significantly lower in patients undergoing antifibrotic treatment compared with non-treated patients. Conclusion Antifibrotic drugs have a beneficial effect on the decline in %FVC in Japanese patients with early-stage IPF who have oxygen desaturation on the 6MWT or increased GAP staging.

Open-Label Study of the Stability of Sublingual Nitroglycerin Tablets in Simulated Real-Life Conditions

2018 ◽  
Vol 122 (12) ◽  
pp. 2151-2156 ◽  
Author(s):  
James J. Nawarskas ◽  
Jason Koury ◽  
David A. Lauber ◽  
Linda A. Felton
Keyword(s):  
Real Life ◽  
Sublingual Nitroglycerin ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Life Conditions ◽  
The Stability
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