Respira Therapeutics, Inc. ya sanar a yau cewa an yi amfani da mai haƙuri na farko a Amurka a cikin gwajin gwaji na multicenter na dan takarar samfurin jagorancinsa, RT234-PAH (vardenafil wanda aka gudanar a matsayin busassun foda mai bushewa). Gwajin VIPAH-PRN 2b (Vardenafil Inhaled for Pulmonary Arterial Hypertension - PRN) zai ƙunshi ƙungiyoyi biyu masu zuwa suna karɓar RT234 a matsayin nau'i guda ɗaya da aka gudanar ta hanyar Axial Oscillating Sphere bushe foda inhaler. An tsara binciken don kimanta aminci da ingancin farko na RT234 don inganta haɓakar alamun episodic da ƙarfin motsa jiki a cikin mutanen da ake bi da su don hauhawar jini na huhu (PAH) tare da Ƙungiyar Zuciya ta New York (NYHA) Alamomin Aiki na Class II-III.
"Ƙaddamar da wannan gwaji na asibiti yana wakiltar wani muhimmin mataki na Respira kuma mataki ne mai mahimmanci na gaba ga yiwuwar ba marasa lafiya tare da PAH magani mai mahimmanci don sarrafa ƙarancin numfashi, wanda ya hana su yin ayyukan yau da kullum," in ji Carol Satler, PhD. , MD, Shugaba da Babban Jami'in Lafiya na Respira. “Mutanen da ke fama da wannan mummunan yanayin da ake fama da su ta hanyar kula da lafiyar jiki har yanzu suna fama da gajeriyar numfashi, gajiya da rashin iya motsa jiki, kuma a halin yanzu babu wasu hanyoyin saurin farawa da ake da su don yin amfani da su kamar yadda ake buƙata don rage ɓangarorin. ”
"Ba da damar marasa lafiya na PAH su kasance masu aiki shine mahimmanci ga lafiyar jiki da tunanin su," in ji Raymond L. Benza, MD, Daraktan Sashen Magungunan Cardiovascular a Jami'ar Jihar Ohio Wexner Medical Center. "Yanzu tare da nazarin RT234, muna nazarin ikonmu na haɓaka aikin jiki lokacin da majiyyaci ya buƙaci shi. Zai iya zama babban ci gaba a yakin da muke da wannan cuta."
Gwajin VIPAH-PRN 2b (RT234-PAH-CL202) nazari ne na haɓaka kashi-kashi don kimanta manyan canje-canje a cikin alamun bayyanar cutar ta RT234 a cikin batutuwa tare da PAH. An yi la'akari da cewa inhaled RT234 (vardenafil inhalation foda) na iya samar da amfanin warkewa don amfani mai yawa a cikin marasa lafiya tare da Hukumar Lafiya ta Duniya (WHO) Rukunin 1 Cutar hawan jini (PH) (Pulmonary Arterial Hypertension [PAH]) don inganta ƙarfin motsa jiki da aiki a ayyukan rayuwar yau da kullun, da kuma rage alamun motsa jiki (misali, dyspnea) da munanan tasirin su akan ingancin rayuwa.
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- 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.
