SPIRIVA® Respimat® efficacy in patients with asthma

Efficacy

The efficacy of adding SPIRIVA® (tiotropium) administered by a soft-mist inhaler (Respimat®) to the treatment regimen of patients with asthma who were already taking long-acting bronchodilators (LABAs) and inhaled corticosteroids (ICS) was studied in two replicate, randomised, placebo-controlled trials (PrimoTinA-asthma® 1 and PrimoTinA-asthma® 2). The trials were conducted in 15 countries and 912 patients were included.1

The results from the clinical trials show that adding tiotropium once daily to ≥800 μg ICS/LABA provided up to 154mL peak FEV1(0-3h) improvement at week 24 (p<0.001)1.


Results - primary outcomes

Improved asthma symptoms

For symptomatic adult asthma patients already using ICS/LABA*, adding SPIRIVA® Respimat® improved asthma symptoms vs control.1,2 The studies also showed that SPIRIVA® Respimat®:

  • Significantly improved lung function1
  • Significantly reduced the risk of severe exacerbations* by a statistically significant 21%1

*Increased time to first severe asthma exacerbation by 56 days compared to placebo (282 days compared to 226 days respectively)1

SPIRIVA® Respimat® improved asthma symptoms

In a pooled analysis of symptomatic patients taking SPIRIVA® Respimat® 5 μg + ≥800 μg ICS/LABA, at week 48, the ACQ-7 responder rate was significantly higher with SPIRIVA® Respimat® + ≥800 μg ICS/LABA, compared to placebo + ≥800 μg ICS/LABA, and patients were thus more likely to have an improvement in their asthma symptoms.2

Significant reduction in the risk of severe asthma exacerbations*

*Severe asthma exacerbations were predefined in the clinical trial protocol as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days, or, in case of ongoing and pre-existing systemic corticosteroid therapy, that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.1

 


Results - secondary outcomes

Reduction in airflow obstruction

At 48 weeks, the mean difference in the change from baseline in peak FEV1 between the tiotropium and placebo groups was 73ml (95% CI 5 to 140, p <0.05) in trial 1 and 152ml (95% CI 87 to 217, p <0.001) in trial 2.1

Increase in the median time to first worsening of asthma

At 48 weeks there was an increase in the median time to the first worsening of asthma of 134 days (315 days in the tiotropium group compared to 181 days in the placebo group) and a reduction in the risk of 31% (HR 0.69, 95% CI 0.58, 0.82, p <0.001).1

Patient reported outcomes (PRO)

The Asthma Control Questionnaire (ACQ-7) scores at week 24 demonstrated a statistically significant improvement between the tiotropium group and the control group in trial 2 (mean difference, -0.20, 95% CI -0.3, -0.07 p=0.003). The result was not statistically significant in trial 1 (mean difference -0.13, 95% CI 0.26, 0.01 p=0.06).1

Increased responder rates

There was a statistically significant improvement in symptom control in patients who received treatment with tiotropium (5µg) compared to placebo. At week 24, 53.9% of patients in the tiotropium group were responders compared to 46.9% of patient who received placebo (odds ratio (OR): 1.32, 95% CI 1.01-1.73, p=0.04). At week 48 there was an increase in the difference in responder rate between the tiotropium group and the placebo group (OR 1.68, 95% CI 1.28-2.21, p <0.001).2

Improvements independent of baseline characteristics

The subgroup analyses showed that improvements in peak FEV1 (0-3h) and trough FEV1 with tiotropium compared to placebo at week 24 were independent of all the patient baseline characteristics assessed (eg, allergic status, smoking status, BMI).2

Safety

Tiotropium Respimat® demonstrated safety and tolerability comparable with placebo.3