Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1

Respiratory Research

Table 1 Overview of placebo-controlled, parallel-group Phase III trials with tiotropium Respimat® in patients aged 12 to 75 years with persistent asthma

Trial	Severity of persistent asthma	Daily required minimum maintenance therapy	ClinicalTrials.gov identifier; main publication	Treatment duration [weeks]	Tiotropium Respimat®		Sal 50	Time of once-daily tiotropium dosing	Number of patients evaluated for efficacy (treated)
	Severity of persistent asthma	Daily required minimum maintenance therapy	ClinicalTrials.gov identifier; main publication	Treatment duration [weeks]	5 μg	2.5 μg	Sal 50	Time of once-daily tiotropium dosing	Number of patients evaluated for efficacy (treated)
Adolescents (12 to 17 years)
RubaTinA-asthma®	Moderate	400–800 μg BUD-eq^a,b	NCT01257230; Hamelmann et al. 2016 [6]	48	✓	✓	–	Evening	397 (397)
PensieTinA-asthma®	Severe	400–800 μg BUD-eq^b + 2 additional controllers^c/ 800–1600 μg BUD-eq^d + 1 additional controller^e,f	NCT01277523; Hamelmann et al., 2016 [7]	12	✓	✓	–	Evening	392 (392)
Adults (18 to 75 years)
GraziaTinA-asthma®	Mild	200–400 μg BUD-eq	NCT01316380; Paggiaro et al., 2016 [8]	12	✓	✓	–	Evening	464 (464)
MezzoTinA-asthma® (2 replicate trials)	Moderate	400–800 BUD-eq^a	NCT01172808/ NCT01172821; Kerstjens et al., 2015 [9]	24	✓	✓	✓	Evening	2081 (2100)
CadenTinA-asthma®	Moderate to severe	400–800 μg BUD-eq^a,g	NCT01340209; Ohta et al., 2015 [10]	52	✓	✓	–	Evening	284 (285)
PrimoTinA-asthma® (2 replicate trials)	Severe	≥800 μg BUD-eq + LABA^a,f	NCT00772538/ NCT00776984; Kerstjens et al., 2012 [11]	48	✓	–	–	Morning	907 (912)
								Total	4525 (4550)

^aLTRA permitted. ^bFor 12–14-year-olds, 200–400 μg BUD-eq was also considered an appropriate medium dose of inhaled corticosteroid.^cTwo controllers of either a LABA, an LTRA or a sustained-release theophylline required. ^dFor 12–14-year-olds, > 400 μg BUD-eq was also considered an appropriate high dose of inhaled corticosteroid. ^eLABA or LTRA required. ^fSustained-release theophylline permitted. ^gLABA permitted
BUD-eq = budesonide or equivalent dose; LABA = long-acting β₂-agonist; LTRA = leukotriene receptor agonist; Sal 50 = salmeterol 50 μg twice daily (morning and evening dosing)

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