The Company is also studying P1101 in the single-arm phase 2B EXCEED-ET trial (ClinicalTrials.gov Identifier: NCT05482971) to evaluate the efficacy, safety, and tolerability of P1101 in adult patients ...
The NDA is supported by data from the open-label, single-center phase 1/2 90-CH-0149 trial and the open-label, single-arm phase 3 09-CH-0059 study.
Budesonide-glycopyrrolate-formoterol does not improve clinical outcomes compared with fluticasone-umeclidinium-vilanterol ...