Boehringer Ingelheim GmbH said the Respimat smoker’s cough inhaler is as safe and effective as its older HandiHaler device, in a study intended to assure users that the new product doesn’t pose a greater risk of death.
Dubbed Tiospir, the company-funded trial followed 17,135 patients with chronic obstructive pulmonary disease, or COPD, for an average of 2.3 years, according to an abstract of the study results published online today by the New England Journal of Medicine. Two groups of patients took Boehringer’s Spiriva drug at one of two doses from the Respimat mist inhaler. A third used the HandiHaler, which administers Spiriva in powder form.
The risks of death and of the disease worsening were the same in the Respimat and HandiHaler groups, the researchers said in the abstract. Boehringer is certain the study will put to rest any safety concerns surrounding the Respimat device, said Klaus Dugi, chief medical officer for the closely held Ingelheim, Germany-based drugmaker.
“We are convinced it will be absolutely sufficient,” Dugi said in a telephone interview. “It’s one of the largest trials ever conducted in COPD.”
A review published in 2011 by the British Medical Journal had found that Spiriva administered in the Respimat inhaler was associated with a 52 percent increase in the risk of mortality, compared with patients given a placebo. Today’s trial didn’t include a placebo comparison.
A sign of more patient deaths on Respimat use in the Tiospir trial would have wiped out Boehringer as a meaningful competitor in COPD treatments, as the drugmaker’s newer medicines for the condition are being tested in the device, analysts at Barclays Plc wrote in a report to investors before the results were released.
Sales of Spiriva climbed 13 percent to 3.6 billion euros ($4.76 billion) last year.
Full results of the trial are scheduled to be presented at the European Respiratory Society’s annual meeting in Barcelona on Sept. 8.