Stopped: The pivotal study failed to meet the primary endpoint. Without a successful readout of the pivotal study, there was no longer a purpose for the supportive BORA-1A-C302 study.
The goal of this clinical trial is to compare the pharmacokinetics (PK) pharmacodynamics (PD), safety and tolerability of acetylsalicylic acid powder for oral inhalation (I-ASA) with non-enteric-coated chewable aspirin (C-ASA) in adult subjects with obstructive or restrictive pulmonary function. In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Peak plasma concentration of ASA (Cmax)
Timeframe: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-inf)
Timeframe: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-t)
Timeframe: pre-dose and 24 hours post-dose