"N" . "RIV/00064190:_____/13:#0000731" . . . "[454C64364044]" . "1"^^ . . . "An open, non-controlled, multicenter, multinational Study to evaluate the Efficacy and Safety of Zemaira\u00AE administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency who completed Clinical Study CE1226_4001"@en . "Praha" . . . . "Otev\u0159en\u00E1, nekontrolovan\u00E1, multicentrick\u00E1, mnohon\u00E1rodn\u00ED studie pro hodnocen\u00ED \u00FA\u010Dinnosti a bezpe\u010Dnosti pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Zemaira p\u0159i chronick\u00E9 roz\u0161i\u0159ovac\u00ED a udr\u017Eovac\u00ED l\u00E9\u010Db\u011B u subjekt\u016F s emfyz\u00E9mem zp\u016Fsoben\u00FDm nedstate\u010Dnost\u00ED inhibitoru alfa-1 protein\u00E1zy, kte\u0159\u00ED dokon\u010Dili klinickou studii CE1226_4001"@cs . "Zkoum\u00E1n\u00ED vlivu Zemaira na progresi emfyz\u00E9mu, posuzovan\u00E9 poklesem hustoty plic, m\u011B\u0159eno ro\u010Dn\u011B pomoc\u00ED po\u010D\u00EDta\u010Dov\u00E9 tomografie (CT). Sekund\u00E1rn\u00ED c\u00EDle studie Posouzen\u00ED \u00FA\u010Dinku l\u00E9\u010Dby A1-PI na po\u010Det, z\u00E1va\u017Enost (po\u010Det dn\u016F hospitalizace kv\u016Fli exacerbaci) a dobu trv\u00E1n\u00ED exacerbac\u00ED. K dal\u0161\u00EDm sekund\u00E1rn\u00EDm c\u00EDl\u016Fm pat\u0159\u00ED posouzen\u00ED - Plicn\u00ED funkce (FEV1 a FEV1/FVC), - Antigenn\u00ED a funk\u010Dn\u00ED s\u00E9rov\u00E9 hladiny A1-PI, - Index t\u011Blesn\u00E9 hmotnosti, - \u00DAmrtnosti, a - Kvality \u017Eivota m\u011B\u0159en\u00E9 pomoc\u00ED St. George Respiratory Questionnaire. Bezpe\u010Dnost Zemaira bude hodnocena podle v\u00FDskytu ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F."@cs . "Otev\u0159en\u00E1, nekontrolovan\u00E1, multicentrick\u00E1, mnohon\u00E1rodn\u00ED studie pro hodnocen\u00ED \u00FA\u010Dinnosti a bezpe\u010Dnosti pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Zemaira p\u0159i chronick\u00E9 roz\u0161i\u0159ovac\u00ED a udr\u017Eovac\u00ED l\u00E9\u010Db\u011B u subjekt\u016F s emfyz\u00E9mem zp\u016Fsoben\u00FDm nedstate\u010Dnost\u00ED inhibitoru alfa-1 protein\u00E1zy, kte\u0159\u00ED dokon\u010Dili klinickou studii CE1226_4001" . . "Otev\u0159en\u00E1, nekontrolovan\u00E1, multicentrick\u00E1, mnohon\u00E1rodn\u00ED studie pro hodnocen\u00ED \u00FA\u010Dinnosti a bezpe\u010Dnosti pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Zemaira p\u0159i chronick\u00E9 roz\u0161i\u0159ovac\u00ED a udr\u017Eovac\u00ED l\u00E9\u010Db\u011B u subjekt\u016F s emfyz\u00E9mem zp\u016Fsoben\u00FDm nedstate\u010Dnost\u00ED inhibitoru alfa-1 protein\u00E1zy, kte\u0159\u00ED dokon\u010Dili klinickou studii CE1226_4001"@cs . "Otev\u0159en\u00E1, nekontrolovan\u00E1, multicentrick\u00E1, mnohon\u00E1rodn\u00ED studie pro hodnocen\u00ED \u00FA\u010Dinnosti a bezpe\u010Dnosti pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Zemaira p\u0159i chronick\u00E9 roz\u0161i\u0159ovac\u00ED a udr\u017Eovac\u00ED l\u00E9\u010Db\u011B u subjekt\u016F s emfyz\u00E9mem zp\u016Fsoben\u00FDm nedstate\u010Dnost\u00ED inhibitoru alfa-1 protein\u00E1zy, kte\u0159\u00ED dokon\u010Dili klinickou studii CE1226_4001" . "An open, non-controlled, multicenter, multinational Study to evaluate the Efficacy and Safety of Zemaira\u00AE administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency who completed Clinical Study CE1226_4001"@en . "Zkoum\u00E1n\u00ED vlivu Zemaira na progresi emfyz\u00E9mu, posuzovan\u00E9 poklesem hustoty plic, m\u011B\u0159eno ro\u010Dn\u011B pomoc\u00ED po\u010D\u00EDta\u010Dov\u00E9 tomografie (CT). Sekund\u00E1rn\u00ED c\u00EDle studie Posouzen\u00ED \u00FA\u010Dinku l\u00E9\u010Dby A1-PI na po\u010Det, z\u00E1va\u017Enost (po\u010Det dn\u016F hospitalizace kv\u016Fli exacerbaci) a dobu trv\u00E1n\u00ED exacerbac\u00ED. K dal\u0161\u00EDm sekund\u00E1rn\u00EDm c\u00EDl\u016Fm pat\u0159\u00ED posouzen\u00ED - Plicn\u00ED funkce (FEV1 a FEV1/FVC), - Antigenn\u00ED a funk\u010Dn\u00ED s\u00E9rov\u00E9 hladiny A1-PI, - Index t\u011Blesn\u00E9 hmotnosti, - \u00DAmrtnosti, a - Kvality \u017Eivota m\u011B\u0159en\u00E9 pomoc\u00ED St. George Respiratory Questionnaire. Bezpe\u010Dnost Zemaira bude hodnocena podle v\u00FDskytu ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F." . "Chlumsk\u00FD, Jan" . . "RIV/00064190:_____/13:#0000731!RIV14-MZ0-00064190" . "To investigate the effect of Zemaira on the progression of emphysema, assessed by the decline of lung density, measured by yearly computed tomography (CT). Secondary objectives of the trial To assess the effect of treatment with A1-PI on the number, severity (number of days of hospitalization due to exacerbation), and duration of exacerbations. Additional secondary objectives include the assessment of - pulmonary function (FEV1 and FEV1/FVC), -antigenic and functional serum A1-PI levels, - body mass index, - mortality, and - quality of life measured by St. George\u2019s Respiratory Questionnaire. The safety of Zemaira\u00AE will be assessed by the occurrence of AEs."@en . . . . "1"^^ . "94846" . . "4"^^ . "CSL Behring GmbH" . . "multinational Study; Zemaira"@en .