Tiotropium delivered by the Respimat Soft Mist Inhaler increases time to first severe exacerbation (p=0.03) and first episode of asthma worsening (p<0.001) compared with placebo in symptomatic asthma patients receiving standard care treatments (ICS/LABA). These improvements were independent of age, allergic status, smoking status and bronchodilator response.(1)
Commenting on the PrimoTinA-asthma subgroup analyses, Dr Richard Russell, Consultant Chest Physician, Wexham Park Hospital (and one of the UK study investigators) said, “These results are extremely encouraging as we continue to investigate tiotropium as a potential treatment for asthma. There remains a significant number of asthma patients who continue to be symptomatic despite available therapeutic options. The results suggest tiotropium may be an efficacious treatment option for patients.”
Given the known effectiveness of tiotropium in COPD and the significant benefit observed in COPD patients with concomitant features of asthma, it was important to investigate whether it could be confirmed that the patients included in the PrimoTinA-asthma Phase III studies had asthma alone.
Presenting the analysis of the baseline characteristics of the PrimoTinA-asthma patient population, Professor David Halpin, Consultant in Respiratory Medicine, Royal Devon and Exeter Hospital, UK, showed that the age of onset, duration of symptoms, smoking status, allergic status and bronchodilator response in the PrimoTinA-asthma patient population provide reasonable certainty that the patients enrolled in these Phase III studies had asthma and not COPD.(2)
Professor Halpin said, “These results provide us with evidence that the patients in these studies, which showed the efficacy of tiotropium, had clinical features typical of asthma, rather than COPD; any similarities to COPD were due to the longstanding nature of their asthma. The efficacy demonstrated in the PrimoTinA-asthma studies therefore represents improvement of the patients’ asthma.”
Despite standard treatment options, an estimated 55% of patients with asthma remain symptomatic and may experience life-threatening asthma exacerbations.(3) All patients in the PrimoTinA-asthma studies were symptomatic despite receiving standard care asthma treatments (ICS/LABA).(1,2)
The PrimoTinA-asthma studies were two replicate double-blind parallel-group trials including asthma patients aged 18–75 years, with a ≥5-year history of asthma, diagnosed before the age of 40 years; and life-long non-smokers or ex-smokers (less than 10 pack-years ) who quit smoking one or more years before study enrolment.(1,2)
A total of 912 patients were randomised to additional tiotropium Respimat 5mcg (n=456) or placebo (n=456) for 48 weeks. In addition to ICS/LABA, patients in the PrimoTinA-asthma studies were permitted to receive additional background therapy, including theophylline, anti-allergic agents, stable systemic steroids and omalizumab.(4)
Asthma diagnosis in the PrimoTinA-asthma patient population was confirmed using criteria in line with current Global Initiative for Asthma guidelines.(2) Patients with a diagnosis of COPD or other lung disease were excluded from the studies.
Severe exacerbations were defined as asthma deterioration necessitating initiation or doubling of systemic glucocorticosteroids.(1)
“Boehringer Ingelheim has a long-established commitment and heritage in respiratory disease. These results are extremely promising as they further demonstrate the potential that once-daily tiotropium Respimat could have across a broad range of patients. Tiotropium has the potential to provide healthcare professionals with an add-on treatment for symptomatic asthmatic patients,” said Dr Brian Wong, Head of UK Medical and Scientific Affairs, Boehringer Ingelheim.
- Kerstjens H.A.M, Tashkin D.P, Engel M. Tiotropium decreases the risk of exacerbations in patients with symptomatic asthma regardless of baseline characteristics. American Thoracic Society (ATS) congress. Philadelphia, Pennsylvania. A0846. 2013.
- Halpin D.M, Bateman E.D, Moroni-Sentgraf P. Tiotropium is effective in patients with severe asthma without evidence of chronic obstructive pulmonary disease. American Thoracic Society (ATS) congress. Philadelphia, Pennsylvania. A40590. 2013.
- Peters S.P, et al. Real-world Evaluation of Asthma Control and Treatment (REACT): Findings from a national Web-based survey. 2007: 1454-1461.
- Kerstjens H.A.M, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367(13):1198-1207.