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    BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension.

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    Author
    Spikes, Leslie A
    Bajwa, Abubakr A
    Burger, Charles D
    Desai, Sapna V
    Eggert, Michael S
    El-Kersh, Karim A
    Fisher, Micah R
    Johri, Shilpa
    Joly, Joanna M
    Mehta, Jinesh
    Palevsky, Harold I
    Ramani, Gautam V
    Restrepo-Jaramillo, Ricardo
    Sahay, Sandeep
    Shah, Trushil G
    Deng, Chunqin
    Miceli, Melissa
    Smith, Peter
    Shapiro, Shelley M
    Show allShow less

    Date
    2022-04-07
    Journal
    Pulmonary Circulation
    Publisher
    SAGE Publications Inc.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1002/pul2.12063
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9063953/
    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).
    Rights/Terms
    © 2022 United Therapeutics Corporation. United Therapeutics Corporation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.
    Keyword
    PAH‐SYMPACT
    dry powder inhaler
    pharmacokinetics
    quality of life
    treprostinil
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/18796
    ae974a485f413a2113503eed53cd6c53
    10.1002/pul2.12063
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