TABLE 6.

Ongoing Phase III studies.

Study ID short title	Main objectives	Study design	Device, dosing regimen, duration	Treatments (number of subjects)	Population (N randomized)	Primary measure(s)	References
COPD
PILASTER	Efficacy, safety, and tolerability	Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group	NEXThaler® Twice-daily (BID) 52 weeks	Tanimilast: Dose 1: 800 µg BID	N = 2,985 moderate to very severe COPD patients with chronic bronchitis and a history of exacerbation on maintenance with triple therapy (ICS, LABA and LAMA)	Primary efficacy variable: Rate of moderate and severe exacerbations, Main secondary variables: Time to 1st moderate or severe exacerbations, predose FEV1,PROs, Safety variables: AEs, AEs of special interests, vital signs, body weight, 12-lead ECGs, routine laboratory values	(PILASTER)
				Dose 2: 1,600 µg BID
				Matched placebo BID
PILLAR	Efficacy, safety, and tolerability	Multicenter, Randomized, Double-blind, Double-dummy, Active and placebo-controlled, Parallel-group	NEXThaler® Twice-daily (BID) 52 weeks	Tanimilast: Dose 1: 800 µg BID	N = 3,980 severe to very severe COPD patients with chronic bronchitis and a history of exacerbation on maintenance with triple therapy (ICS, LABA and LAMA)	Primary efficacy variable: Rate of moderate and severe exacerbations, Main secondary variables: Time to 1st moderate or severe exacerbations, predose FEV1, PROs, Safety variables: AEs, AEs of special interests, vital signs, body weight, 12-lead ECGs, routine laboratory values	(PILLAR)
				Dose 2: 1,600 µg BID
				Roflumilast
				500 µg OD
				Matched placebo