Table 2 Study designs.
From: Asthma exacerbations and worsenings in patients aged 1–75 years with add-on tiotropium treatment
Study name (ClinicalTrials.gov number) | Asthma severity | Tiotropium Respimat dose | Patients (N)a | Study duration (weeks) | Patient age (years)b | History of asthmab | ACQ mean scoreb | Lung function (FEV1 % predicted)b,c,d |
|---|---|---|---|---|---|---|---|---|
PrimoTinA-asthma (NCT00772538)19 | Severe | Tiotropium (5 µg QD) vs. placebo + LABA as add-on to ICS (800 µg budesonide/equivalent) | 459 | 48 | 18–75 | ≥5 years | ≥1.5 | ≤80% |
PrimoTinA-asthma (NCT00776984)19 | Severe | Tiotropium (5 µg QD) vs. placebo + LABA as add-on to ICS (800 µg budesonide/equivalent) | 453 | 48 | 18–75 | ≥5 years | ≥1.5 | ≤80% |
MezzoTinA-asthma (NCT01172808)20 | Moderate | Tiotropium (5 or 2.5 µg QD) vs. LABA vs. placebo as add-on to ICS (400–800 µg budesonide/equivalent) | 1071 | 24 | 18–75 | 3 months | ≥1.5 | 60–90% |
MezzoTinA-asthma (NCT01172821)20 | Moderate | Tiotropium (5 or 2.5 µg QD) vs. LABA vs. placebo as add-on to ICS (400–800 µg budesonide/equivalent) | 1032 | 24 | 18–75 | 3 months | ≥1.5 | 60–90% |
GraziaTinA-asthma (NCT01316380)21 | Mild | Tiotropium (5 or 2.5 µg QD) vs. placebo as add-on to ICS (200–400 µg budesonide/equivalent) | 465 | 12 | 18–75 | 3 months | ≥1.5 | 60–90% |
PensieTinA-asthma (NCT01277523)15 | Severe | Tiotropium (5 or 2.5 µg QD) vs. placebo + ≥1 controller therapy as add-on to high-dose ICS > 400 µg budesonide/equivalent in patients aged 12–14 years and 800–1600 µg budesonide/equivalent in patients aged 15–17 years) or ≥2 controller therapies as add-on to medium-dose ICS (200–400 µg budesonide/equivalent in patients aged 12–14 years and 400–800 µg budesonide/equivalent in patients aged 15–17 years) | 392 | 12 | 12–17 | ≥3 months | ≥1.5 | 60–90% |
RubaTinA-asthma (NCT01257230)14 | Moderate | Tiotropium (5 or 2.5 µg QD) vs. placebo ± LTRA as add-on to ICS (200–800 µg budesonide/equivalent in patients aged 12–14 years and 400–800 µg budesonide/equivalent in patients aged 15–17 years) | 398 | 48 | 12–17 | ≥3 months | ≥1.5 | 60–90% |
VivaTinA-asthma (NCT01634152)18 | Severe | Tiotropium (5 or 2.5 µg QD) vs. placebo + ≥1 controller therapy as add-on to high-dose ICS (>400 µg budesonide/equivalent) or ≥2 controller therapies as add-on to medium-dose ICS (200–400 µg budesonide/equivalent) | 401 | 12 | 6–11 | ≥6 months | ≥1.5 | 60–90% |
CanoTinA-asthma (NCT01634139)17 | Moderate | Tiotropium (5 or 2.5 µg QD) vs. placebo ± LTRA as add-on to ICS (200–400 µg budesonide/equivalent) | 403 | 48 | 6–11 | ≥6 months | ≥1.5 | 60–90% |
NinoTinA-asthma (NCT01634113)16 | Persistent asthmatic symptoms | Tiotropium (5 µg or 2.5 µg QD) vs. placebo ± additional maintenance therapies as add-on to ICS (dose not reported) | 102 | 12 | 1–5 | ≥6-month history of persistent asthmatic symptoms | Not reported | ≤90%e |
