Boehringer Presents New Phase III Data for Asthma Therapy Tiotropium

Boehringer Presents New Phase III Data for Asthma Therapy Tiotropium

Boehringer IngelheimPharmaceutical company Boehringer Ingelheim recently presented encouraging data regarding its investigational drug tiotropium delivered through the company’s Respimat inhaler, for the treatment of asthma. The data was presented at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, which took place in Houston, Texas.

The company released updates on five Phase III clinical studies conducted within its UniTinA-asthma program, which revealed tiotropium’s ability to improve the lung function of mild, moderate and severe asthma in adult patients, according to pre-planned analyses from the GraziaTinA study. These patients were already being treated with maintenance therapies, but continued to experience disease symptoms.

“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, from the Boys Town National Research Hospital in 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.”

Boehringer is evaluating the efficacy and safety of tiotropium as a once-daily add-on treatment, despite the fact that it hasn’t yet been approved for this indication. It is designed for patients with asthma whose symptoms, such as wheezing, shortness of breath, chest tightness and cough, are resistant to maintenance treatments like inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA).

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

[adrotate group=”3″]

The company’s researchers conducted five double-blind, placebo-controlled, parallel-group clinical studies, including 3,480 mild, moderate and severe asthma patients. The participants were given doses of 5 mcg or 2.5 mcg tiotropium or placebo, as well as ICS with or without LABA. In addition, the scientists evaluated the patients’ total serum immunoglobulin E, blood eosinophils, and allergies.

Two PrimoTinA-asthma trials were conducted with patients who suffer from severe asthma who had symptoms despite high-doses of ICS therapy and LABA therapy, as well as two other MezzoTinA-asthma trials including patients with moderate asthma and symptoms resistant to medium-dose ICS therapy. A last GraziaTinA-asthma trial was conducted, enrolling patients with mild asthma who were also unresponsive to low-doses of ICS.

Interaction P-Values

Study

Peak

FEV1 (0-3hr)

Trough
FEV1

IgE

PrimoTinA

0.74

0.62

MezzoTinA

0.97

0.84

GraziaTinA

0.16

0.63

Eosinophil
count

PrimoTinA

0.70

0.75

MezzoTinA

0.24

0.51

GraziaTinA

0.38

0.36

Investigator
Judgment

PrimoTinA

0.21

0.41

MezzoTinA

0.62

0.67

GraziaTinA

0.60

0.87

The studies revealed significant improvements in peak FEV1 (0-3hr) and trough FEV1 in patients who were administered tiotropium through the Respimat inhaler, in comparison with the patients who received placebo, irrespective of underlying allergic status, as demonstrated in the table above. In addition, the company reported that the most common adverse events were asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis and upper respiratory tract infection.

In addition to asthma, Boehringer Ingelheim also presented the benefits of tiotropium in patients with chronic obstructive pulmonary disease (COPD). While it is known that inhaled therapies can reduce the risk of exacerbations, the researchers were interested in the effects of treatment on mortality, and discovered in a follow-up study the efficacy of tiotropium in significantly reducing the rate of hospitalization in high-risk patients.

Leave a Comment

Your email address will not be published. Required fields are marked *