Barb; this test shows that 6 mg gives .35 liter improvements in fev1 hope they don't take forever to approve (erj.ersjournals.com/content/48/suppl_60/PA4052) its a good read. God bless
I like the word PROFOUND
RPL554, an inhaled PDE3/4 inhibitor, causes
profound and sustained bronchodilation in healthy volunteers and COPD patients
Dave Singh, Kathy Banner, Kenneth Newman
European Respiratory Journal 2016 48: PA4052; DOI: 10.1183/13993003.congress-2016.PA4052
ArticleFigures & DataInfo & Metrics
Abstract
RPL554 has previously been shown to be a well tolerated bronchodilator, bronchoprotective, & anti-inflammatory agent in clinical studies. We performed a randomised, double blind, placebo (PBO) controlled, study to assess the safety, tolerability & pharmacokinetics of single ascending (SAD) & multiple ascending doses (MAD) (5.5 days bid) of a new pH neutral, commercially scalable inhaled suspension RPL554 formulation administered by nebuliser to healthy subjects (HV) & stable COPD patients. Each cohort comprised 7-9 active & 3 PBO treated subjects. RPL554 was well tolerated at all dose levels in HV & COPD patients. As part of this study, the effect of RPL554 on FEV1 up to 24h post dose was studied. Single doses of RPL554 (1.5, 3, 6, 12, 24mg) caused a profound sustained dose dependent increase in FEV1 in HV (Fig 1). MAD of RPL554 administered to HV (6, 12, 24mg) & COPD patients (1.5, 6, 12mg) also caused marked increases in FEV1 at all doses tested with a duration supportive of bid dosing. In summary, this new suspension formulation of RPL554, which has potential benefits in terms of dose levels & stability, is a potent bronchodilator drug with what appears to be a large safety margin. This potent & sustained bronchodilator activity in combination with its' anti-inflammatory activity make RPL554 a promising new potential therapy for COPD & other obstructive lung diseases.
