Boehringer Ingelheim has presented eagerly-awaited data which confirms that the mist version of Spiriva has similar safety and exacerbation efficacy compared to the older dry powder version of the chronic obstructive pulmonary disease blockbuster.

Data from the landmark TIOSPIR trial has been presented at the European Respiratory Society conference in Barcelona comparing Spiriva (tiotropium) delivered through the Respimat soft mist inhaler (5mcg) and by the HandiHaler device (18mcg). The three-year, plus-17,000 patient trial, one of the largest COPD studies ever conducted, included patients with the full range of severities, showed no difference between Respimat and HandiHaler in risk of death or of first exacerbation, on-treatment all-cause mortality and incidents of cardiovascular adverse events.

Specifically, the median time to the first COPD exacerbation was more than two years for Respimat (756 days) and HandiHaler (719 days). The results clearly put to bed safety fears raised from a meta-analysis in more than 6,500 patients published in 2011 which claimed that  taking Spiriva via Respimat device was linked to a 52% increase in the risk of death compared to  placebo.

Boehringer vigorously defended Respimat at the time, pointing out that the findings of the pooled data were flawed. Commenting on TIOSPIR, Richard Russell of the Wexham Park Hospital in the UK, said the results” have been hugely anticipated and hopefully will draw a line under the debate on the safety and efficacy profile of Respimat”.

He added that the results “provide clear evidence” that Respimat has “an equally good mortality profile in COPD patients…including those with a history of cardiac disease”. Brian Wong, head of UK medical and scientific affairs at Boehringer, noted that the study “was designed to answer a specific question” and “we hope that these results reassure healthcare professionals that they can provide a choice of device to their COPD patients”.

As well as providing a boost for Spiriva, which had first-half sales of 1.83 billion euros (+4%), the TIOSPIR data augurs well for Boehringer’s well-stocked respiratory pipeline, most notably its once-daily LABA/LAMA fixed-dose combination olodaterol/tiotropium.