Boehringer Ingelheim presents Phase III data for tiotropium at 2015 AAAAI Annual Meeting

Feb 24 2015

Boehringer Ingelheim today presented data on investigational tiotropium delivered via Respimat^® inhaler from five Phase III trials from the UniTinA-asthma^® program at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas. Pre-planned analyses from the program, including new data from the GraziaTinA study, showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies, improved lung function as measured by peak forced expiratory volume in one second (FEV_{1 (o-3hr)}) and trough FEV₁, independent of underlying allergic status. Tiotropium is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

“A significant number of asthma patients continue to experience symptoms despite treatment with available therapies and it is important to understand how a patient’s allergic status might impact their response to treatment,” said Kevin Murphy, MD, Boys Town National Research Hospital, Omaha, Nebraska. “These data showed that the addition of tiotropium delivered via Respimat inhaler improved lung function in adults with asthma across a range of severities independent of underlying allergic status.”

Tiotropium is being studied as a once-daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., 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 in these analyses were double-blind, placebo-controlled, parallel-group trials in adult patients with mild, moderate and severe asthma. A total of 3,480 patients were randomized for the five trials to receive tiotropium 5 μg, 2.5 μg or placebo in addition to ICS with or without LABA. Three criteria were used to determine whether or not a patient had allergies: total serum immunoglobulin E (IgE, < or =430μg/L [equivalent to 179.2 IU/L]), blood eosinophils (< or =0.6×10⁹/L), or investigator judgment (No/Yes). Patients were permitted to receive additional background therapy, which varied from trial to trial, and included treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab.

The Phase III studies included in these analyses were:

• Two PrimoTinA-asthma^® trials (NCT00772538/NCT00776984) in patients with severe asthma who remained symptomatic while receiving high-dose ICS therapy plus LABA therapy
• Two MezzoTinA-asthma^® trials (NCT01172808/NCT01172821) in patients with moderate asthma who remained symptomatic while receiving medium-dose ICS therapy
• One GraziaTinA-asthma trial (NCT01316380) in patients with mild asthma who remained symptomatic while receiving low-dose ICS treatment

Peak FEV_{1 (0-3hr)} and trough FEV₁ significantly improved with the addition of tiotropium delivered via the Respimat inhaler compared to placebo, irrespective of underlying allergic status.

The adverse event (AE) data presented is pooled from the five Phase III trials in adults. The most commonly reported AEs, by preferred term, from the pooled analyses were asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis and upper respiratory tract infection.

“Allergic asthma is the most common form of asthma and new and additional treatment options are needed to help manage this disease,” said Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “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.”