COPD drug could be used to treat asthma patients

Patients with poorly controlled asthma are a step closer to a new treatment option, after Phase III data showed that Boehringer Ingelheim’s lung drug Tiotropium, significantly reduced exacerbations and improved both lung function and quality of life.

The phase III research, presented at the European Respiratory Society conference in Vienna, also showed adding the once daily drug could cut the risk of any asthma exacerbation by 31%.

Tiotropium, a long-acting inhaled bronchodilator commonly used to treat chronic obstructive pulmonary disease (COPD), is currently unlicensed for treating asthma.

Spiriva, which is known chemically as Tiotropium is delivered by the Respimat Soft Mist inhaler. The research was published in the New England Journal of Medicine. Tiotropium has comprehensive clinical trial data, demonstrating an extensive wealth of experience since its introduction almost 10 years ago and over 25million patient years of real life experience, to support the efficacy and safety profile.

However, there remain concerns over the drug’s risk in patients with heart disease. Last year an analysis published by the British Medical Journal, found that the use of Spiriva delivered in a mist form (via Respimat), was linked with a 52% increase in the risk of death.

Boehringer Ingelheim said, “It did not agree with the authors conclusion that there is an increased mortality risk for Spiriva Respimat in COPD, and that its risks and benefits were included in its label.”

The German drug maker went on to say, “There were also significant improvements in lung function, asthma control and asthma related quality of life, lending further weight to the case for its use in controlling the disease. The need for new and effective asthma treatments is great, because a significant proportion of patients remain symptomatic and may experience asthma exacerbations, despite current therapies.”

In two trials supported by the drug’s marketers, Boehringer Ingelheim and Pfizer, researchers recruited 912 patients with asthma already taking inhaled glucocorticoids and long-acting beta-agonists (LABAs).

Despite their drug regimen, all patients remained symptomatic and had at least one severe exacerbation within the past year. Researchers randomised these patients to receive either Tiotropium once daily or placebo alongside their usual treatment. These were administered using a soft mist inhaler.

The team found that after 24 weeks patients receiving Tiotropium went on average 282 days without a first exacerbation, 21% longer than those on placebo, who experienced an exacerbation within an average of 226 days. The effects were sustained over 24 hours. Adverse events were similar between treatment and placebo groups.

The researchers concluded that, “In patients with poorly controlled asthma despite treatment with inhaled glucocorticoids and LABAs, adding Tiotropium significantly reduced the risk of episodes of the worsening of asthma and asthma exacerbations, requiring treatment with systemic glucocorticoids and provided sustained bronchodilation.”