Table 2. Comparison of lung function and clinical findings from clinical trialsa with long-acting anticholinergic bronchodilators in asthma.
Authors | Severity b | Duration per treatment, weeks | N | Study drug(s) | Comparator(s) | Primary and key secondary end points | Difference from comparator c |
---|---|---|---|---|---|---|---|
Peters et al. 27 | Mild to moderate asthma inadequately controlled by low-dose ICS | 14 | 210 | Once-daily tiotropium 18 μg, via Spiriva HandiHaler | Doubling ICS dose | Morning PEF | 25.8 l/min (95% CI: 14.4–37.1; P<0.001) |
Doubling ICS dose | Daily symptom score | −0.11 points (P<0.001) | |||||
Salmeterol | Morning PEF | No significant difference | |||||
Salmeterol | Daily symptom score | No significant difference | |||||
Kerstjens et al. 26 | Severe asthma inadequately controlled by high-dose ICS + LABA | 8 | 107 | Once-daily tiotropium 5 μg, via Respimat SoftMist | Placebo | Tiotropium 5 μg, peak FEV1 | 139 ml (95% CI: 96–181; P<0.0001) |
Asthma-related health status or symptoms | No significant difference | ||||||
Once-daily tiotropium 10 μg, via Respimat SoftMist | Tiotropium 10 μg, peak FEV1 | 170 ml (95% CI: 128–213; P<0.001) | |||||
Asthma-related health status or symptoms | No significant difference | ||||||
Bateman et al. 25 | Mild to moderate asthma uncontrolled by ICS alone | 16 | 38 | Once-daily tiotropium 5 μg, via Respimat SoftMist | Placebo (following run-in with salmeterol)d | Morning pre-dose PEF | −20.70 l/min (95% CI: −33.24 to −8.16; P=0.001 for superiority) |
Salmeterol (following run-in with salmeterol)d | Morning pre-dose PEF | −0.78 l/min (95% CI: −13.096 to 11.530; P=0.002 for non-inferiority) | |||||
Kerstjens et al. 28 | Poorly controlled asthma despite use of ICS + LABA | 48 | 912 | Once-daily tiotropium 5 μg, via Respimat SoftMist | Placebo | Peak FEV1 at week 24 | 86±34 ml (P=0.01) (trial 1); 154±32 ml (P<0.001) (trial 2) |
Trough FEV1 at week 24 | 88±31 ml (P=0.01) (trial 1); 111±30 ml (P=0.001) (trial 2) | ||||||
Reduction in risk of severe exacerbation at week 48 | 21% (hazard ratio 0.79; P<0.03) (pooled population) | ||||||
Difference in AQLQ | 0.04 units, NS (trial 1)e 0.18 units, P=0.02 (trial 2)e | ||||||
Difference in ACQ-7 | −0.13, NS (trial 1)e −0.2, P=0.003 (trial 2)e |
Abbreviations: ACQ-7, seven-question Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; FEV1, forced expiratory volume in 1 s; ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; NS, not significant; PEF, peak expiratory flow.
Only studies published in journal primary publication format have been included (Kerstjens et al. 76,77 and Beeh et al. 75 not shown).
All studies were in adults.
All lung function values are mean change from baseline, unless otherwise stated.
Active treatments were evaluated as maintenance therapies following a 4-week run-in period with salmeterol.
Minimal clinically important difference not achieved.