Once-daily Spiriva® has a new indication and is now 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 ICS (≥800µg budesonide/day or equivalent) and LABA and who experienced one or more severe exacerbations in the previous year.
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® 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%)
• Reduced the risk of experiencing a severe exacerbation by more than one fifth (21%)
• Delayed the time to first episode of asthma worsening (315 days versus 181 days)
In the Phase III studies, the overall incidence of adverse events was comparable between patients in the Spiriva® Respimat® and placebo groups. 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.
“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. 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.”
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. It is already licensed for the treatment of chronic obstructive pulmonary disease (COPD).