Chief Medical Officer states that " As NTM infections in CF patients results in significant mobility and may become life threatening we invite our entire panel of experts today to comment as they see fit on the unmet needs and the potential for ARIKACE. As Will mentioned earlier today we are presenting data from our Phase 3 clinical of ARIKACE and Cystic fibrosis patients six years of age and older chronic Pseudomonas aeruginosa lung infection.
Chronically infected eligible patients with FEV1, 25% of predicted or greater were randomize in this study based on age and lung function strata to receive either once daily ARIKACE or twice daily TOBI for three cycles. Each cycle comprised of 28 days on treatment and 28 days off treatment. Upon completion of this study eligible patients were involved in the two year open label multi-cycle study of ARIKACE CLEAR-110. The primary endpoint of the phase III study is relative change in forced expiratory volume in one second or FEV-1 from baseline day one of the study to the end of pre-treatment cycles, study day 168 or approximately six months. "
Chronically infected eligible patients with FEV1, 25% of predicted or greater were randomize in this study based on age and lung function strata to receive either once daily ARIKACE or twice daily TOBI for three cycles. Each cycle comprised of 28 days on treatment and 28 days off treatment. Upon completion of this study eligible patients were involved in the two year open label multi-cycle study of ARIKACE CLEAR-110. The primary endpoint of the phase III study is relative change in forced expiratory volume in one second or FEV-1 from baseline day one of the study to the end of pre-treatment cycles, study day 168 or approximately six months. "
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