Tiotropium delivered by the Respimat(R) Soft Mist(TM) Inhaler (SMI) increases time to first severe exacerbation and first episode of asthma worsening across a broad spectrum of patients who remain symptomatic despite at least inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) therapy.
The results are from pre-planned subgroup analyses of data from the PrimoTinA-asthma(TM) Phase III studies being presented for the first time today at the 2013 American Thoracic Society (ATS) congress in Philadelphia, Pennsylvania.
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.
The PrimoTinA-asthma studies are part of Boehringer Ingelheim's comprehensive ongoing Phase III trial programme named UniTinA-asthma, which was designed to establish the efficacy and safety of tiotropium, delivered by the Respimat Soft Mist Inhaler (SMI) in patients with asthma. UniTinA-asthma includes trials in adults, adolescents and children and involves over 4,000 patients in more than 150 sites globally.
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-asthmapatient 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. "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 thePrimoTinA-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).
The PrimoTinA-asthma studies were two replicate double-blind parallel-group trials including asthma patients aged 18-75 years, with a greater than or equal to5-year history of asthma, diagnosed before the age of 40 years; and life-long non-smokers or ex-smokers (less than 10 pack-years 1 pack of cigarettes daily for 10 years) who quit smoking one or more years before study enrollment.
A total of 912 patients were randomized to additional tiotropium Respimat 5 mcg (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.
Asthma diagnosis in the PrimoTinA-asthma patient population was confirmed using criteria in line with current Global Initiative for Asthma guidelines. 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.
Tiotropium delivered by Respimat is not licensed for the treatment of asthma.