Asthma: Spiriva® (tiotropium) Respimat® becomes the only LAMA licensed in asthma care

Boehringer Ingelheim announced today that adult asthma patients could benefit from a new treatment. Once-daily Spiriva® delivered via the Respimat® Soft Mist™ Inhaler (SMI) has a new indication, licensed in the UK as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of ICS¹ (≥800µg budesonide/day or equivalent) and LABA[2] and who experienced one or more severe exacerbations in the previous year.

Spiriva® Respimat® has been granted this new indication based on the PrimoTinA-asthma® Phase III studies in adults with asthma who continue to have symptoms despite best-practice management with at least ICS + LABA. The studies showed that compared to the addition of placebo to usual care, the addition of Spiriva® Respimat® to current treatment:

• Reduced the number of patients who had a severe asthma exacerbation (26.9% versus 32.8%)¹
• Reduced the risk of experiencing a severe exacerbation by more than one fifth (21%)¹
• Delayed the time to first episode of asthma worsening (315 days versus 181 days)¹

In the Phase III studies, the overall incidence of adverse events was comparable between patients in the Spiriva® Respimat® and placebo groups.¹ The most commonly reported adverse events in both the Spiriva® Respimat® and placebo groups were asthma events, decreased rate of peak expiratory flow and common cold.¹  

“We have over 90 years’ experience in the field of respiratory medicine and we are committed to bringing new treatment options to patients particularly in areas of high unmet need,” said Dr Charles De Wet, Medical Director UK and Ireland at Boehringer Ingelheim. “Launching Spiriva® Respimat® in asthma is a first for this class of medicine and we are delighted to lead the way.”

Commenting on the results, he continued, “The results from the Phase III PrimoTinA-asthma® studies to date demonstrate that the addition of Spiriva® Respimat® to current therapies is both efficacious and generally well-tolerated in symptomatic, adult asthma patients.”

Today, asthma is often seen as an easy to manage condition and there is a misconception that people with asthma are all well controlled. However, earlier this year  the Royal College of Physicians’ ‘National Review of Asthma Deaths’ shone a light on the high unmet treatment need in asthma and the number of deaths over the course of a year that could have been prevented with better management.⁴ The prevalence of asthma in the UK is among the highest in the world, with 4.3 million adults currently receiving treatment.⁵ However, an estimated 55% of patients with asthma remain symptomatic.³

Commenting on the new indication for Spiriva® Respimat® in asthma, Dr Brian Lipworth, Scottish Centre for Respiratory Research, Ninewells Hospital, Dundee said, “Over half of asthma sufferers still experience symptoms despite taking current treatments and this leaves them at a worryingly high risk of experiencing an asthma attack. With such high numbers of people left vulnerable, the need for new and effective treatments is clear. This licence for Spiriva® Respimat® gives doctors a much needed new option to protect patients against asthma attacks, which can at best be unpleasant, and at worst, life threatening”

Spiriva® Respimat® is an inhaled long-acting, anticholinergic bronchodilator.  It works by opening narrowed airways and helps to keep them open for at least 24 hours.^6,7,8 It  is already licensed for the treatment of chronic obstructive pulmonary disease (COPD).

1. Kerstjens HAM, et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367: 1198-1207
2. Price D, et al. The burden of ICS- and LABA-treated asthma patients in the UK adult population. Thorax 2013; 68 (Suppl 3): A82. P17  
3. Demoly P, et al. Repeated cross-sectional survey of patient reported asthma control in Europe in the past 5 years. Eur Respir Rev 2012; 21: 66-74
4. Royal College of Physicians. National Review of Asthma Deaths. 2014.
5. Asthma UK. Asthma facts and FAQs. http://www.asthma.org.uk/asthma-facts-and-statistics Last accessed: September 2014
6. Casaburi R, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19: 217-224.
7. Celli B, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124: 1743-1748
8. Casaburi R, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127: 809-817