Boehringer Ingelheim has revealed new Phase III data on tiotropium, which showed that the drug candidate improves lung function in adult patients with mild, moderate and severe asthma irrespective of allergic status.
The company presented the data on investigational tiotropium delivered through Respimat inhaler from five Phase III trials from the UniTinA-asthma programme at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas, US.
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During the programme, tiotropium was studied as a once-daily, add-on treatment in asthma patients who continue to experience symptoms such as wheezing, shortness of breath, chest tightness and cough, despite the use of maintenance therapy including inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA).
The studies included double-blind, placebo-controlled, parallel-group trials in a total of 3,480 adult patients with mild, moderate and severe asthma, who were randomised for the five trials, including two PrimoTinA-asthma trials, two MezzoTinA-asthma trials and one GraziaTinA-asthma trial.
The patients recieved tiotropium 5mcg, 2.5mcg or placebo in addition to ICS with or without LABA, and were also permitted to receive additional background therapy that varied from trial to trial, and included treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab.
Data obtained from the study indicated that tiotropium improved lung function in subjects as measured by peak forced expiratory volume in one second (FEV1 (0-3hr)) and trough FEV1 compared to placebo, independent of underlying allergic status.
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By GlobalDataBoehringer Ingelheim Pharmaceuticals Clinical Development and Medical Affairs, Respiratory vice-president Danny McBryan said: "Allergic asthma is the most common form of asthma and new and additional treatment options are needed to help manage this disease.
"These data add to our understanding of the safety and efficacy of adding tiotropium to maintenance therapies in patients who remain symptomatic despite available asthma treatments."
Tiotropium is being investigated to determine its efficacy and safety in treating asthma patients, even though it is not currently approved for this indication.
