Tiotropium Respimat® Add-On To Inhaled Corticosteroids Improves Lung Function In Patients With Symptomatic Mild Asthma: Results From A Phase III Trial

A randomized, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma

“…There was no indication that BID dosing offered additional benefit over OD dosing. These results are in line with studies of tiotropium in asthma, which have failed to demonstrate a convincing doseeresponse with the doses established for use in COPD [20,21]. However, the data are in contrast to studies in COPD where UMEC demonstrated a doseeordered response in trough FEV 1 across a similar range of OD doses [14].…”

“…In the serial assessment subgroup, measurements were performed pre-dose on Day 1 (within 1 h prior to dosing) and at 5, 15, and 30 min, and 1, 3, and 6 h post-dose. On Day 14 (continuing into Day 15), FEV 1 was measured pre-dose (within 1 h prior to dosing) and at 5, 15, and 30 min, and 1, 3,6,9,12,16,20,23, and 24 h post-dose. PEF, asthma symptoms, and rescue albuterol use were recorded using electronic diaries throughout the study, including screening and washout periods, to identify any periods of asthma worsening.…”

Current role of anticholinergic drugs in the treatment of asthma: key messages for clinical practice

“…13 The TALC trial 16 was the only published study to investigate the role of tiotropium in mild-to-moderate asthma, though an additional trial has been presented as an abstract. 17 In the other studies, [15][16][17][18][19] the severity of asthma was moderate. The primary outcome was morning peak expiratory flow (PEF) in 2 studies, 15,16 peak forced expiratory volume in 1 second (FEV 1 ) in 2 studies, 17,18 and peak FEV 1 area under the curve from zero to 24 hours in 1 study.…”

“…17 In the other studies, [15][16][17][18][19] the severity of asthma was moderate. The primary outcome was morning peak expiratory flow (PEF) in 2 studies, 15,16 peak forced expiratory volume in 1 second (FEV 1 ) in 2 studies, 17,18 and peak FEV 1 area under the curve from zero to 24 hours in 1 study. 19 In another manuscript, which comprised of 2 replicate RCTs, prespecified coprimary endpoints were peak and trough FEV 1 and asthma control.…”

“…Tiotropium in mild-to-moderate asthma The role of tiotropium in mild-to-moderate asthma or in moderate asthma has been investigated in various randomized, double-blind, placebo-controlled clinical trials (RCTs) [15][16][17][18][19][20][21][22] with a duration that ranged from 4 to 52 weeks (TABLE 1), and reviewed in a recent meta-analysis. 13 The TALC trial 16 was the only published study to investigate the role of tiotropium in mild-to-moderate asthma, though an additional trial has been presented as an abstract.…”