I-Respira Therapeutics, Inc. imemezele namuhla ukuthi isiguli sokuqala e-United States sifakwe umthamo esivivinyweni se-multicenter sekhandidethi lomkhiqizo walo oholayo, i-RT234-PAH (i-vardenafil elawulwa njenge-powder eyomile yokwelashwa). Isivivinyo se-VIPAH-PRN 2b (i-Vardenafil Inhaled for Pulmonary Arterial Hypertension - PRN) izoba nama-cohorts amabili alandelanayo athola i-RT234 njengezilinganiso ezilodwa ezilawulwa nge-Axial Oscillating Sphere dry powder inhaler. Ucwaningo luklanyelwe ukuhlola ukuphepha nokusebenza kokuqala kwe-RT234 ukuze kuthuthukiswe ngokujulile izimpawu ze-episodic namandla okuzivocavoca kubantu abalashelwa i-pulmonary arterial hypertension (PAH) ngezimpawu ze-New York Heart Association (NYHA) ezisebenzayo zeClass II-III.
"Ukuqaliswa kwalolu cwaningo lomtholampilo kumelela ingqophamlando ebalulekile ye-Respira futhi kuyisinyathelo esilandelayo esibalulekile ekunikezeni iziguli ezine-PAH ukwelashwa okunamandla ukuze zilawule ukuphefumula kwazo, okubavimbela ukuba benze imisebenzi evamile yansuku zonke," kusho uCarol Satler, PhD. , MD, uMongameli kanye noMphathi Omkhulu Wezokwelapha we-Respira. “Abantu abaphethwe yilesi simo esicindezelayo futhi esibucayi abalashwa ngamakhambi esondlo basahlangabezana neziqephu zokuphefumula, ukukhathala nokungakwazi ukuzivocavoca, okwamanje azikho izindlela zokwelapha ezisheshayo ezitholakalayo ‘njengoba kudingeka’ ukuze kwehliswe lezi ziqephu. ”
"Ukuvumela iziguli ze-PAH ukuba zisebenze kakhulu kuyisihluthulelo sempilo yabo engokomzimba nengqondo," kusho uRaymond L. Benza, MD, uMqondisi we-Division of Cardiovascular Medicine e-Ohio State University Wexner Medical Center. “Manje ngocwaningo lwe-RT234, sihlola amandla ethu okuthuthukisa ukuvivinya umzimba lapho isiguli sikudinga. Kungase kube yisinyathelo esihle phambili empini yethu nalesi sifo.”
Isivivinyo se-VIPAH-PRN 2b (RT234-PAH-CL202) siwucwaningo lokwenyuka komthamo ukuze kuhlolwe izinguquko ezibucayi ezimpawu ngemuva kokuthatha umthamo we-RT234 ezihlokweni ezine-PAH. Kucatshangwa ukuthi i-RT234 ephefumulayo (i-vardenafil inhalation powder) ingase inikeze inzuzo yokwelapha ukuze isetshenziswe kanzima ezigulini ezine-World Health Organization (WHO) Iqembu le-1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension [PAH]) ukuthuthukisa amandla okuzivocavoca nokusebenza imisebenzi yokuphila kwansuku zonke, kanye nokunciphisa izimpawu zokuzikhandla (isb, i-dyspnea) kanye nomthelela wazo oyingozi kukhwalithi yempilo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- It is hypothesized that inhaled RT234 (vardenafil inhalation powder) may provide a therapeutic benefit for acute use in patients with World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension [PAH]) to improve exercise capacity and performance in activities of daily living, as well as reduce exertional symptoms (e.
- “The initiation of this clinical trial represents an important milestone for Respira and is a critical next step in potentially offering patients with PAH an acute treatment to manage their shortness of breath, which prevents them from performing normal daily duties,”.
- The study is designed to evaluate the safety and preliminary efficacy of RT234 to acutely improve episodic symptoms and exercise capacity in people being treated for pulmonary arterial hypertension (PAH) with New York Heart Association (NYHA) Functional Class II-III symptoms.
