BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension
Abstract Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time in...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-04-01
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| Series: | Pulmonary Circulation |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/pul2.12063 |
| _version_ | 1797748954938474496 |
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| author | Leslie A. Spikes Abubakr A. Bajwa Charles D. Burger Sapna V. Desai Michael S. Eggert Karim A. El‐Kersh Micah R. Fisher Shilpa Johri Joanna M. Joly Jinesh Mehta Harold I. Palevsky Gautam V. Ramani Ricardo Restrepo‐Jaramillo Sandeep Sahay Trushil G. Shah Chunqin Deng Melissa Miceli Peter Smith Shelley M. Shapiro |
| author_facet | Leslie A. Spikes Abubakr A. Bajwa Charles D. Burger Sapna V. Desai Michael S. Eggert Karim A. El‐Kersh Micah R. Fisher Shilpa Johri Joanna M. Joly Jinesh Mehta Harold I. Palevsky Gautam V. Ramani Ricardo Restrepo‐Jaramillo Sandeep Sahay Trushil G. Shah Chunqin Deng Melissa Miceli Peter Smith Shelley M. Shapiro |
| author_sort | Leslie A. Spikes |
| collection | DOAJ |
| description | Abstract Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty‐one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six‐minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ‐ITD]), PAH Symptoms and Impact (PAH‐SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug‐related serious AEs. Statistically significant improvements occurred in 6MWD, PQ‐ITD, and PAH‐SYMPACT. Forty‐nine patients completed the 3‐week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well‐tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient‐reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739). |
| first_indexed | 2024-03-12T16:13:21Z |
| format | Article |
| id | doaj.art-54bf8d2f543344f38ef9f1658923dfa4 |
| institution | Directory Open Access Journal |
| issn | 2045-8940 |
| language | English |
| last_indexed | 2024-03-12T16:13:21Z |
| publishDate | 2022-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pulmonary Circulation |
| spelling | doaj.art-54bf8d2f543344f38ef9f1658923dfa42023-08-09T10:21:08ZengWileyPulmonary Circulation2045-89402022-04-01122n/an/a10.1002/pul2.12063BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertensionLeslie A. Spikes0Abubakr A. Bajwa1Charles D. Burger2Sapna V. Desai3Michael S. Eggert4Karim A. El‐Kersh5Micah R. Fisher6Shilpa Johri7Joanna M. Joly8Jinesh Mehta9Harold I. Palevsky10Gautam V. Ramani11Ricardo Restrepo‐Jaramillo12Sandeep Sahay13Trushil G. Shah14Chunqin Deng15Melissa Miceli16Peter Smith17Shelley M. Shapiro18Pulmonary and Critical Care Medicine University of Kansas Medical Center Kansas City Kansas USAPulmonary Medicine Ascension St. Vincent's Hospital Southside Jacksonville Florida USAPulmonary Medicine Mayo Clinic Jacksonville Florida USAHeart Failure and Transplantation Cardiology Ochsner Medical Center New Orleans Louisiana USAPulmonary and Critical Care Medicine Sentara Heart Hospital Norfolk Virginia USAPulmonary and Critical Care Medicine University of Nebraska Medical Center Omaha Nebraska USAPulmonary and Critical Care Medicine Emory University School of Medicine Atlanta Georgia USAPulmonary and Critical Care Medicine Henrico Doctors' Hospital and Bon Secours St. Francis Medical Center Richmond Virginia USACardiology, Heart Failure and Transplantation Cardiology University of Alabama at Birmingham Birmingham Alabama USAPulmonary and Critical Care Medicine The Cleveland Clinic Weston Florida USAPulmonary Medicine University of Pennsylvania Philadelphia Pennsylvania USACardiology University of Maryland School of Medicine Baltimore Maryland USAPulmonology and Critical Care Medicine University of South Florida College of Medicine Tampa Florida USAPulmonary Hypertension and Pulmonary Critical Care Houston Methodist Hospital Houston Texas USAPulmonary and Critical Care Medicine University of Texas Southwestern Medical Center Dallas Texas USAClinical Product Development United Therapeutics Corporation Research Triangle Park North Carolina USAGlobal Medical Affairs United Therapeutics Corporation North Carolina Research Triangle Park USAClinical Product Development United Therapeutics Corporation Research Triangle Park North Carolina USAPulmonology, Greater Los Angeles VA Healthcare System Cardiology Section, and David Geffen UCLA School of Medicine Los Angeles California USAAbstract Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty‐one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six‐minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ‐ITD]), PAH Symptoms and Impact (PAH‐SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug‐related serious AEs. Statistically significant improvements occurred in 6MWD, PQ‐ITD, and PAH‐SYMPACT. Forty‐nine patients completed the 3‐week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well‐tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient‐reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739).https://doi.org/10.1002/pul2.12063dry powder inhalerPAH‐SYMPACTpharmacokineticsquality of lifetreprostinil |
| spellingShingle | Leslie A. Spikes Abubakr A. Bajwa Charles D. Burger Sapna V. Desai Michael S. Eggert Karim A. El‐Kersh Micah R. Fisher Shilpa Johri Joanna M. Joly Jinesh Mehta Harold I. Palevsky Gautam V. Ramani Ricardo Restrepo‐Jaramillo Sandeep Sahay Trushil G. Shah Chunqin Deng Melissa Miceli Peter Smith Shelley M. Shapiro BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension Pulmonary Circulation dry powder inhaler PAH‐SYMPACT pharmacokinetics quality of life treprostinil |
| title | BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension |
| title_full | BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension |
| title_fullStr | BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension |
| title_full_unstemmed | BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension |
| title_short | BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension |
| title_sort | breeze open label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as tyvaso dpi™ in patients with pulmonary arterial hypertension |
| topic | dry powder inhaler PAH‐SYMPACT pharmacokinetics quality of life treprostinil |
| url | https://doi.org/10.1002/pul2.12063 |
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