Boehringer Ingelheim today announced data from Phase 2 and Phase 3 studies from the Company's ongoing clinical trial program investigating the efficacy and safety of tiotropium in asthma. These data were presented at the American Thoracic Society International Conference (ATS 2013) in Philadelphia, Pennsylvania.
To determine whether the effect on bronchodilation and time to first severe exacerbation seen in severe asthma patients in the two Phase 3 PrimoTinA-asthma™ studies was limited to definable subgroups of patients, pre-planned subgroup analyses of the data were carried out. The PrimoTinA-asthma™ studies were replicate trials evaluating once-daily tiotropium delivered via the Respimat® inhaler in patients with severe persistent asthma.
The pre-planned subgroup analyses demonstrated that tiotropium delivered once daily via the Respimat® inhaler showed promising results across a broad spectrum of patients with severe persistent asthma who remained symptomatic and experienced exacerbations despite current treatment with at least high-dose inhaled corticosteroids (ICS) and/or long-acting beta2 agonists (LABA).
"These analyses show that the results for time to first severe exacerbation and first episode of asthma worsening found with the addition of tiotropium may not be limited to specific subgroups of patients," said Professor Huib A. M. Kerstjens of the University Medical Centre, Groningen, The Netherlands, and one of the main authors on the presented studies. "Asthma affects patients with all kinds of medical histories and backgrounds. These results suggest tiotropium's promise independent of patients' baseline characteristics, providing an important clinical insight into tiotropium's potential in asthma treatment."
Neither the time to first severe exacerbation nor the time to first episode of asthma worsening was dependent on baseline characteristics, some of which are usually found in patients with chronic obstructive pulmonary disease (COPD), such as former smoking, non-allergic status or minimal bronchodilator response.
It was also important to investigate whether patients included in the PrimoTinA-asthma™ Phase 3 studies were identified to have asthma alone and not comorbid COPD.
In a separate study presented at ATS, further analysis of the PrimoTinA-asthma™ data suggested that improvements in lung function seen in the Phase 3 studies were related to tiotropium's potential role in asthma and not due to comorbid COPD diagnosis, as strict criteria were used to ensure patients enrolled in the studies had a confirmed diagnosis of asthma and that patients with COPD were excluded.
"Despite current treatment options, approximately 40 percent of people with asthma remain symptomatic and may experience life-threatening asthma exacerbations," said Tunde Otulana , MD, acting head, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Finding new advancements for the growing number of people affected by asthma remains one of Boehringer Ingelheim's priorities, and we are encouraged to see additional data reinforcing tiotropium's potential as an additional treatment option for asthma patients who remain symptomatic on current therapies."
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