Boehringer releases positive Phase III trial results of tiotropium Respimat in asthma patients

4th March 2014 (Last Updated March 4th, 2014 01:00)

Boehringer Ingelheim has reported positive results from large-scale Phase III studies demonstrating that once-daily tiotropium delivered via the Respimat inhaler was effective and well-tolerated in patients across asthma severities.

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Boehringer Ingelheim has reported positive results from large-scale Phase III studies demonstrating that once-daily tiotropium delivered via the Respimat inhaler was effective and well-tolerated in patients across asthma severities.

The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego, US.

The first results from the Phase III GraziaTinA-asthma trial showed that tiotropium Respimat improved lung function and was well-tolerated in patients with asthma who remain symptomatic, while receiving low-dose maintenance ICS treatment.

University of Pisa professor of Respiratory Medicine and lead author on the GraziaTinA-asthma trial Pierluigi Paggiaro said: "It is important to investigate the efficacy and safety of new treatment options across different asthma severities."

"It is important to investigate the efficacy and safety of new treatment options across different asthma severities."

The company has also released data of a new subset from the Phase III PrimoTinA-asthma trials, which showed that in patients with asthma who remained symptomatic while receiving moderate-dose maintenance ICS therapy, the addition of once-daily tiotropium reduced airflow obstruction independent of allergic status, as measured by the TH2 phenotype biomarker.

Finally, an analysis of a subset from the trials found the addition of once-daily tiotropium improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA).

The effect was demonstrated in patients with asthma who remained symptomatic despite receiving treatment with at least ICS/LABA.

The company said that previous results from these PrimoTinA-asthma trials have shown that the addition of tiotropium Respimat significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening, compared with at least ICS/LABA therapy alone.

Tiotropium Respimat is not currently approved for use in asthma, except in Colombia.


Image: Boehringer Ingelheim Center (BIC), the Corporate Headquarters Building. Photo: courtesy of Boehringer Ingelheim GmbH.