Respira Therapeutics, Inc. na faasilasilaina i le asō o le tagata muamua na maua i le Iunaite Setete ua faʻataʻitaʻiina i le multicenter faʻataʻitaʻiga o lona sui tauva oloa taʻitaʻia, RT234-PAH (vardenafil faʻatonuina e pei o se paʻu mamago togafitiga inhaled). O le VIPAH-PRN 2b faʻataʻitaʻiga (Vardenafil Inhaled for Pulmonary Arterial Hypertension - PRN) o le a aofia ai ni faʻasologa faʻasolosolo se lua e mauaina le RT234 e pei o tui e tasi e faʻatinoina e ala i le Axial Oscillating Sphere dry powder inhaler. O le suʻesuʻega ua mamanuina e iloilo ai le saogalemu ma le aoga muamua o le RT234 e faʻaleleia atili ai faʻamaoniga episodic ma faʻamalositino malosi i tagata o loʻo togafitia mo le toto maualuga o le pulmonary arterial (PAH) ma New York Heart Association (NYHA) Functional Class II-III symptoms.

"O le amataina o lenei faʻataʻitaʻiga faʻataʻitaʻiga e fai ma sui o se mea taua tele mo Respira ma o se laasaga taua tele i le tuʻuina atu o tagata mamaʻi i le PAH se togafitiga faʻapitoa e pulea ai le manava manava, lea e taofia ai i latou mai le faia o tiute masani i aso taitasi," o le tala lea a Carol Satler, PhD. , MD, Peresetene ma Fomaʻi Sili o Respira. "O tagata o loʻo mafatia i lenei tulaga faʻavaivaia ma ogaoga o loʻo togafitia i togafitiga faʻaleleia o loʻo feagai pea ma vaega o le manava, vaivai ma le le mafai ona faʻamalositino, ma o loʻo i ai i le taimi nei e leai ni togafitiga faʻavavevave e avanoa mo 'pe a manaʻomia' faʻaoga e faʻaitiitia ai nei vaega. ”

"O le faʻamalosia o tagata gasegase o le PAH e sili atu le malosi o le ki lea i lo latou soifua maloloina faaletino ma le mafaufau," o le tala lea a Raymond L. Benza, MD, Faʻatonu o le Vaega o Faʻafomaʻi Faʻataʻitaʻi i le Ohio State University Wexner Medical Center. "O le taimi nei ma le suʻesuʻega o le RT234, o loʻo matou suʻesuʻeina lo matou gafatia e faʻamalosia le gaioiga faaletino pe a manaʻomia e se maʻi. Atonu o se la'asaga lelei tele lea i le tatou taua ma lenei fa'ama'i.”

O le su'esu'ega VIPAH-PRN 2b (RT234-PAH-CL202) o se su'esu'ega fa'atuputeleina o fuala'au e iloilo ai suiga tetele i fa'ailoga pe a mae'a le fa'aogaina o le RT234 i mataupu e iai le PAH. O loʻo faʻapea o le inhaled RT234 (vardenafil inhalation powder) e mafai ona maua ai se faʻamanuiaga faʻapitoa mo le faʻaaogaina o tagata mamaʻi ma le World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hightension [PAH]) e faʻaleleia ai le malosi o le faamalositino ma le faʻatinoga i totonu. gaoioiga o le olaga i aso uma, fa'apea fo'i le fa'aitiitia o fa'ailoga fa'amalositino (fa'ata'ita'iga, dyspnea) ma o latou a'afiaga leaga i le lelei o le olaga.

OA MEA E AVEA MAI LENEI TUSI:

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.