PMID- 36034402
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220830
IS  - 2045-8932 (Print)
IS  - 2045-8940 (Electronic)
IS  - 2045-8932 (Linking)
VI  - 12
IP  - 3
DP  - 2022 Jul
TI  - INSPIRE: Safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary 
      arterial hypertension (PAH).
PG  - e12119
LID - 10.1002/pul2.12119 [doi]
LID - e12119
AB  - The INSPIRE trial was a Phase 3, open-label, multicenter trial (LTI-301) that 
      enrolled patients with pulmonary arterial hypertension (PAH) >/= 18 years of age 
      who transitioned to Yutrepia from nebulized treprostinil (Transition) or added 
      Yutrepia to prostacyclin naive patients on </=2 nonprostacyclin oral therapies. The 
      objectives of the trial were to evaluate the safety and tolerability of 
      Yutrepia (dry-powder formulation of treprostinil) in patients with PAH. The 
      primary safety measures were the incidence of adverse events (AEs) and serious 
      AEs. Exploratory efficacy measures were also assessed during the trial. 
      Transition patients initiated Yutrepia at a dose comparable to their nebulized 
      treprostinil dose while prostacyclin naive patients received 26.5-mcg QID; 
      up-titration in 26.5-mcg increments was permitted for both groups. A total of 121 
      patients were enrolled, of which 29 patients discontinued from the trial, with 
      the most common reason being AEs. Eighty percent of the Transition group and 96% 
      of the prostacyclin naive group titrated to a dose >/=79.5 mcg QID at Day 360, 
      respectively, with one patient achieving a dose of 212-mcg QID. The most common 
      AEs were cough, headache, upper respiratory tract infection, dyspnea, dizziness, 
      throat irritation, diarrhea, chest discomfort, fatigue, and nasopharyngitis. Most 
      of these events were considered treatment-related though mild to moderate in 
      severity and expected for prostacyclin therapy administered by inhalation. In an 
      evaluation of exploratory efficacy measures, patients remained stable or improved 
      over the 1 year of treatment. Yutrepia was found to be a convenient, safe, and 
      well-tolerated inhaled prostacyclin treatment option for PAH patients.
CI  - (c) 2022 The Authors. Pulmonary Circulation published by John Wiley & Sons Ltd on 
      behalf of Pulmonary Vascular Research Institute.
FAU - Hill, Nicholas S
AU  - Hill NS
AUID- ORCID: 0000-0002-8242-8339
AD  - Tufts Medical Center Boston Massachusetts USA.
FAU - Feldman, Jeremy P
AU  - Feldman JP
AD  - Arizona Pulmonary Specialists, Ltd Phoenix Arizona USA.
FAU - Sahay, Sandeep
AU  - Sahay S
AUID- ORCID: 0000-0002-0672-1680
AD  - Weill Cornell Medicine, Houston Methodist Lung Center, Houston Methodist Houston 
      Texas USA.
FAU - Benza, Raymond L
AU  - Benza RL
AD  - The Ohio State University Columbus Ohio USA.
FAU - Preston, Ioana R
AU  - Preston IR
AD  - Tufts Medical Center Boston Massachusetts USA.
FAU - Badesch, David
AU  - Badesch D
AD  - Anschutz Medical Campus, University of Colorado Denver Aurora Colorado USA.
FAU - Frantz, Robert P
AU  - Frantz RP
AD  - Mayo Clinic Rochester Minnesota USA.
FAU - Patel, Savan
AU  - Patel S
AD  - Liquidia Technologies Morrisville North Carolina USA.
FAU - Galloway, Ashley
AU  - Galloway A
AD  - Liquidia Technologies Morrisville North Carolina USA.
FAU - Bull, Todd M
AU  - Bull TM
AD  - Anschutz Medical Campus, University of Colorado Denver Aurora Colorado USA.
CN  - INSPIRE study investigators
LA  - eng
PT  - Journal Article
DEP - 20220701
PL  - United States
TA  - Pulm Circ
JT  - Pulmonary circulation
JID - 101557243
PMC - PMC9400582
OTO - NOTNLM
OT  - combination therapy
OT  - dry-powder inhaler
OT  - prostacyclin
OT  - pulmonary arterial hypertension
OT  - treprostinil
COIS- N. S. H.: Liquidia and Aerovate, consulting fees; Altavant, lectures, 
      presentations, speakers bureaus, manuscript writing, and/or educational events; 
      Liquidia, expert testimony; Liquidia, support for attending meetings and/or 
      travel; Merck and United Therapeutics, data safety monitoring board or advisory 
      board. J. P. F.: Liquidia, advisory board. S. S.: ACCP CHEST and United 
      Therapeutics, research grants; Liquidia, steering committee; Gossamer Bio, United 
      Therapeutics, and Bayer, advisor; Bayer, United Therapeutics, and Johnson & 
      Johnson, speaker; Johnson & Johnson, planned patent; Bayer, advisory board; GSK, 
      endpoint adjudication committee. R. L. B.: Bayer, Abbot, United Therapeutics, 
      Abbott, Gossamer Bio, and Acceleron, consulting fees; Society of Heart and Lung 
      Transplantation and the Pulmonary Vascular Disease Institute, leadership and/or 
      fiduciary role. I. R. P.: Janssen, United Therapeutics, PhaseBio, and Tenax, 
      research grants and/or contracts; Altavant, Janssen, United Therapeutics, and 
      Liquidia, consulting fees; Medscape and Med on the Go, lectures, presentations, 
      speakers bureaus, manuscript writing and/or educational events; Bayer, expert 
      testimony; Altavant, Janssen, United Therapeutics, and Liquidia, data safety 
      monitoring or advisory board; ISHLT, leadership or fiduciary role. D. B.: 
      Acceleron, Arena/United Therapeutics, Altavant, Actelion/Janssen/Johnson & 
      Johnson, Ikaria, Reata, Complexa Liquidia, and Merck, research grants; Acceleron, 
      Altavant, Bayer, Merck, and Liquidia, consulting fees; Practice Point 
      Communications, lectures, presentations, speakers bureaus, manuscript writing 
      and/or educational events; Bayer, expert testimony; United Therapeutics, data 
      safety or advisory board; USPHSR (United States Pulmonary Hypertension Scientific 
      Registry), leadership or fiduciary role; Johnson & Johnson, stock or stock 
      options. R. P. F.: NHLBI, research grant; Up to Date, royalties or licenses; 
      Janssen, Liquidia, Shouti, Altavant, Gossamer Bio, Bayer, and Tenax, consulting 
      fees; United Therapeutics, France Foundation, and Janssen, lectures, 
      presentations, speakers bureaus, manuscript writing and/or educational events; 
      Janssen and Liquidia, data safety or advisory board; Tenax, stock or stock 
      options. S. P.: Liquidia, employee, stock or stock options. A. G.: Liquidia, 
      employee, attending meetings and/or travel patents, and stock or stock options. 
      T. M. B.: Bayer, research grant; Liquidia and Bayer, steering committee and 
      consulting fees; NHLBI and MESA, data safety and/or advisory board.
EDAT- 2022/08/30 06:00
MHDA- 2022/08/30 06:01
PMCR- 2022/07/01
CRDT- 2022/08/29 05:07
PHST- 2022/04/05 00:00 [received]
PHST- 2022/07/11 00:00 [revised]
PHST- 2022/07/17 00:00 [accepted]
PHST- 2022/08/29 05:07 [entrez]
PHST- 2022/08/30 06:00 [pubmed]
PHST- 2022/08/30 06:01 [medline]
PHST- 2022/07/01 00:00 [pmc-release]
AID - PUL212119 [pii]
AID - 10.1002/pul2.12119 [doi]
PST - epublish
SO  - Pulm Circ. 2022 Jul 1;12(3):e12119. doi: 10.1002/pul2.12119. eCollection 2022 
      Jul.