TABLE 1

Overview of clinical trials of tiotropium Respimat in adult patients with symptomatic asthma

Trial [ref.]Asthma severityKey trial background medicationKey spirometric entry criteriaTreatment armAdjusted mean difference in response compared with placebo
ICS dose# µgLABAPeak FEV1 mLTrough FEV1 mLMorning PEF L·min−1Evening PEF L·min−1
NCT00365560 [54]Severe≥800Yes≤80% of predicted post-BD FEV1 FEV1 ≤70% of FVCTiotropium 10 µg once daily170 (p<0.001, n=103)113 (p<0.002, n=103)15.3 (p<0.001, n=103)23.3 (p<0.001, n=103)
Tiotropium 5 µg once daily139 (p<0.001, n=104)86 (p<0.001, n=104)7.9 (p=0.02, n=104)14.7 (p<0.001, n=104)
NCT00350207+ [55]Moderate400–1000No≤90% of predicted pre-BD FEV1Tiotropium 5 µg once dailyND149## (p<0.001, n=128)20.7 (p=0.001, n=128)23.6 (p=0.001, n=128)
Salmeterol 50 µg twice dailyND167 (p<0.001, n=134)21.5 (p=0.001, n=134)20.2 (p=0.001, n=134)
NCT01233284+ [56]Moderate400–800No60–90% of predicted pre-BD FEV1Tiotropium 5 µg once daily188 (p<0.001, n=143)143 (p<0.001, n=143)20.8 (p<0.0001, n=143)21.6 (p<0.0001, n=143)
Tiotropium 2.5 µg once daily128 (p<0.001, n=144)132 (p<0.001, n=144)17.9 (p<0.0001, n=144)14.6 (p<0.0001, n=144)
Tiotropium 1.25 µg once daily139 (p<0.001, n=144)125 (p<0.001, n=144)18.6 (p<0.0001, n=144)21.3 (p<0.0001, n=144)
NCT01152450+ [57]Moderate400–800No60–90% of predicted pre-BD FEV1Tiotropium 5 µg once daily131 (p<0.01, n=90)133 (p<0.01, n=90)22 (p<0.01, n=88)29 (p<0.01, n=89)
Tiotropium 2.5 µg twice daily132 (p<0.01, n=89)111 (p<0.01, n=89)21 (p<0.01, n=89)30 (p<0.01, n=89)
NCT00772538, NCT00776984§ [58]Severe≥800Yes≤80% of predicted post-BD FEV1 FEV1 ≤70% of FVCTiotropium 5 µg once daily110 (p<0.0001, n=422)93 (p<0.0001, n=421)22.6 (p<0.0001, n=411)26.4 (p<0.0001, n=408)
NCT01172808, NCT01172821ƒ [59]Moderate400–800No60–90% of predicted pre-BD FEV1Tiotropium 5 µg once daily185 (p<0.0001, n=481)146 (p<0.0001, n=481)24.3 (p<0.0001, n=472)23.2 (p<0.0001, n=472)
Tiotropium 2.5 µg once daily223 (p<0.0001, n=492)180 (p<0.0001, n=492)25.4 (p<0.0001, n=485)22.1 (p<0.0001, n=483)
Salmeterol 50 µg twice daily196 (p<0.0001, n=510)114 (p<0.0001, n=510)24.8 (p<0.0001, n=501)20.7 (p<0.0001, n=499)
  • All analyses performed on the full analysis set. ICS: inhaled corticosteroids; LABA: long-acting β2-agonist; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; PEF: peak expiratory flow; BD: bronchodilator (salbutamol); ND: not defined. #: budesonide or equivalent; : phase II study in adults with severe asthma; +: phase II study in adults with moderate asthma; §: phase III study in adults with severe asthma; ƒ: phase III study in adults with moderate asthma; ##: defined as morning pre-dose FEV1.