5 results
* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…
Primary Objective(s):1. To determine whether aging associated cognitive impairment can be attenuated by roflumilast administration as assessed by cognitive battery tests.Secondary Objective(s):1. To determine whether brain electrical activity (ie,…
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
The primary objective is to examine whether roflumilast (a PDE-4 inhibitor) can improve the cognition of healthy young volunteers. Secondary, we will assess the effects of roflumilast on electrophysiological correlates of cognition.