Tiotropium Improves Lung Function, Regardless of Allergic Status, Study Reports

Adding tiotropium Respimat treatment in adult patients with mild, moderate, and severe asthma who continue to experience symptoms despite the use of maintenance therapies significantly improved lung function, according to a presentation by Boehringer Ingelheim scientists at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, TX.

New data from the GraziaTinA study indicated favorable results when including tiotropium Respimat treatment as measured by peak expiratory volume in one second (FEV1 (o-3hr)) and trough FEV1, independent of underlying allergic status.

Kevin Murphy, MD, Boys Town National Research Hospital, Omaha, NE, commented, “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. 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.”

The researchers conducted a trial with 3,480 patients to gauge the success rate of Tiotropium as a once-daily, add-on treatment in asthma patients who continued to experience symptoms like wheezing, shortness of breath, chest tightness, and cough, despite the use of existing maintenance therapy such as inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA).

The patients were randomized for5 trials to receive tiotropium 5 μg, 2.5 μg or placebo in addition to ICS with or without LABA.

Three main 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).

Researchers noted that patients were allowed to receive additional background therapy, including treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab. Also, the most common adverse events reported reported were asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis, and upper respiratory tract infection.

The following Phase III studies were included in the analyses:

· 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

The results found that peak FEV1 (0-3hr) and trough FEV1 significantly improved when a tiotropium combination delivered via the Respimat inhaler compared to placebo, regardless of their allergic status.

Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc., concluded, “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.”