Table 2 Comparison of lung function and clinical findings from clinical trials a with long-acting anticholinergic bronchodilators in asthma

From: Is there a rationale and role for 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

  1. 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.
  2. aOnly studies published in journal primary publication format have been included (Kerstjens et al.76,77 and Beeh et al.75 not shown).
  3. bAll studies were in adults.
  4. cAll lung function values are mean change from baseline, unless otherwise stated.
  5. dActive treatments were evaluated as maintenance therapies following a 4-week run-in period with salmeterol.
  6. eMinimal clinically important difference not achieved.
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