Boehringer Ingelheim Pharmaceuticals, Inc. Release: New Phase 3 Study Shows Investigational Tiotropium Improves Lung Function In Adolescent Patients With Symptomatic Asthma

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RIDGEFIELD, Conn., Sept. 8, 2014 /PRNewswire/ -- Boehringer Ingelheim today presented new data from the company's Phase III trial program (UniTinA-asthma®) evaluating tiotropium in asthma, including the first study assessing the efficacy and safety of tiotropium in adolescent patients with symptomatic asthma. These data were unveiled during an oral session at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany. Tiotropium is being studied to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

The first presentation of Phase III results from the RubaTinA-asthma® (NCT01257230) study demonstrated tiotropium's potential benefit among adolescents with moderate persistent asthma. The data presented at ERS show tiotropium 5 mcg delivered via the Respimat® inhaler statistically significantly improved lung function, as measured by forced expiratory volume in one second (FEV1) response, in adolescent patients with asthma who remain symptomatic.

"Asthma is a leading cause of chronic illness among young people in the U.S.," said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. "The results of this Phase III trial provide important insight into the potential role of investigational tiotropium in treating adolescent patients who require additional asthma control despite treatment with usual maintenance therapy."

In the Phase III RubaTinA-asthma® study, adolescent asthma patients (12-17 years) were randomized to receive once-daily tiotropium 5 mcg, tiotropium 2.5 mcg or placebo as add-on to inhaled corticosteroids (ICS) maintenance therapy over 48 weeks. The primary endpoint was peak FEV1a measure of the amount of air exhaled in one secondwithin three hours of dosing (FEV1(0-3h) response), evaluated at Week 24. Additional endpoints included other breathing measurement tests, evaluations of symptom control and assessments of adverse events (AEs).

Tiotropium 5 mcg delivered via the Respimat® inhaler demonstrated statistically significant improvement across lung function measurements, as compared to placebo, at 24 and 48 weeks.


Tiotropium Respimat 5
mcg

Tiotropium Respimat 2.5
mcg


24 weeks

48 weeks

24 weeks

48 weeks

Mean Peak
FEV1(03h)

174 mL
(p=0.0005)

134 mL
(p=0.0085)

174 mL
(p=0.0006)

176 mL
(p=0.0007)

Trough
FEV1

117 mL
(p=0.0320)

157 mL
(p=0.0044)

84 mL
(p=0.1307)

137 mL
(p=0.0154)

PEFam +/-
SE*

15.82 L/min
+/- 6.87
(p=0.02)

19.62 L/min
+/- 7.02
(p<0.01)

9.72 L/min
+/- 7.04
(p=0.17)

14.04 L/min
+/- 7.17
(p=0.05)

PEFpm +/-
SE*

16.69 L/min
+/- 6.73
(p=0.01)

18.21 L/min
+/- 6.85
(p<0.01)

12.25 L/min
+/- 6.90
(p=0.08)

15.27 L/min
+/- 7.05
(p=0.03)

*Adjusted mean difference plus/minus standard error

Overall, AEs were reported in 62.7 percent of those treated with tiotropium 5 mcg, 63.2 percent of those treated with tiotropium 2.5 mcg and 59.4 percent of those in the placebo group. The most common individual AEs were asthma, nasopharyngitis, viral respiratory tract infection and headache.

"Finding new therapies for the growing number of people living with and affected by asthma is an important priority for Boehringer Ingelheim," said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are encouraged by these latest data from the UniTinA-asthma® program and they are an important addition to the growing data supporting the potential use of tiotropium in treating asthma patients across ages and severities. These data indicate tiotropium's potential benefit in asthma may be extended to adolescents who continue to need additional treatment options for their asthma."

Additional Data Presented at ERS 2014
During the same oral session today, Boehringer Ingelheim presented data from a secondary analysis of six Phase III studies from the UniTinA-asthma® clinical trial program involving adults with symptomatic asthma. In the six studies, once-daily tiotropium was given as add-on treatment to patients with varying severities of asthma who remained symptomatic despite maintenance therapy of ICS or ICS/long-acting beta agonist (LABA).

To measure asthma control, investigators looked at the Asthma Control Questionnaire (ACQ-7) score of patients in previous Phase III studies of tiotropium in asthma. The definition of responder used in this trial was characterized as patients with an improvement in responder rate of at least 0.5 for the ACQ.

Data from the analysis demonstrate that the addition of once-daily tiotropium delivered via the Respimat® inhaler to maintenance asthma therapy is associated with an improvement in asthma control responder rate, as measured by the ACQ-7, among adult patients with mild, moderate and severe symptomatic asthma.


ACQ-7 Responder Rate n (%)


Tiotropium
Respimat
5 mcg

Tiotropium
Respimat
2.5 mcg

Placebo
Respimat

PrimoTinA Week 48
(NCT00772538/6984)

263 (58.1)

--

205 (45.2)

MezzoTinA Week 24
(NCT01172808/2821)

330 (64.3)

332 (64.5)

299 (57.7)

GraziaTinA Week 12
(NCT01316380)

90 (58.1)

91 (59.1)

91 (58.7)

CadenTinA - Week 52
(NCT01340209)

87 (76.3)

81 (71.1)

41 (73.2)

Additionally at ERS 2014, a pooled study evaluating the safety of tiotropium compared to placebo in five Phase III and one Phase II trial was presented. In the six trials, adults with asthma received tiotropium delivered via the Respimat® inhaler as add-on to at least ICS maintenance therapy.


Adverse Event Occurring in >2 percent of Patients


Tiotropium
Respimat 5 mcg

Tiotropium
Respimat 2.5 mcg

Placebo
Respimat

Any AE

58.3 percent

52.0 percent

61.3 percent

Serious AE

4.1 percent

1.8 percent

4.4 percent

The most common individual AEs were asthma, peak expiratory flow (PEF) rate decrease and nasopharyngitis.

About the UniTinA-Asthma® Clinical Trial Program
The comprehensive Phase III trial program, UniTinA-asthma®, includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic on maintenance treatment with at least inhaled corticosteroid (ICS). The program includes over 4,000 patients in more than 150 sites globally.

About Asthma
Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction. When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

As of December 2012, an estimated 300 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow by an additional 100 million people worldwide by 2025.

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease in many patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic.

Leading Respiratory Forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.com

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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