Welcome!

News Feed Item

Boehringer Ingelheim Presents Phase 3 Data for Tiotropium Across Asthma Severities

For U.S. Media Only

RIDGEFIELD, Conn., March 1, 2014 /PRNewswire/ -- Boehringer Ingelheim today presented data from Phase 3 studies of tiotropium delivered via the Respimat® inhaler in mild, moderate and severe asthma patients at the 2014 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Diego. Tiotropium is being studied to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

The first results from the Phase 3 GraziaTinA-asthma® study (NCT01316380) were presented at the meeting, and showed that tiotropium delivered via the Respimat® inhaler improved lung function response, as measured by forced expiratory volume in one second (FEV1), in patients with mild asthma who remained symptomatic while receiving low-dose inhaled corticosteroid (ICS) treatment.

A pre-specified subset of data from the Phase 3 MezzoTinA-asthma® trials (NCT01172808/NCT01172821) presented at the meeting showed that, in patients with moderate asthma who remained symptomatic while receiving medium-dose ICS therapy, the addition of once-daily tiotropium reduced airflow obstruction independently of allergic status, as measured by the TH2 phenotype biomarkers.

Another subset of data presented at AAAAI found the addition of once-daily tiotropium in the Phase 3 PrimoTinA-asthma® trials (NCT00772538/NCT00776984) improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA) in patients with severe asthma.

"Even with current treatment options, approximately 40 percent of patients with asthma remain symptomatic," said Pierluigi Paggiaro, MD, Professor of Respiratory Medicine, University of Pisa, and lead author on the GraziaTinA-asthma® presentation. "It is important to investigate the efficacy and safety of new treatment options across different severities."

GraziaTinA-Asthma® Data Presented at AAAAI

The GraziaTinA-asthma® trial is a Phase 3, randomized, double-blind, parallel-group trial designed to evaluate tiotropium delivered via the Respimat® inhaler as an add-on treatment in patients with persistent asthma who remain symptomatic while receiving at least low-dose maintenance ICS treatment (200-400 mcg budesonide equivalent). The primary endpoint was FEV1 peak(0-3h) response (change from baseline) at 12 weeks. The key secondary endpoint was trough FEV1. Additional secondary endpoints included FEV1 area under the curve (AUC(0-3h)), peak expiratory flow (PEF) responses (measured with the AM2+® device) and Asthma Control Questionnaire (ACQ-7) score. Of 464 treated patients, 155 received tiotropium 5 mcg, 154 received tiotropium 2.5 mcg, and 155 received placebo.

In the study, both tiotropium doses were statistically significant compared to placebo in FEV1 peak(0-3h) response and in trough FEV1 response at Week 12:


Peak FEV1(0-3h) Response

(adjusted mean difference)

Trough FEV1 Response

(adjusted mean difference)

5 mcg

128 mL (P = 0.0005)

122 mL (P = 0.001)

2.5 mcg

159 mL (P < 0.0001)

110 mL (P = 0.0028)

The FEV1 AUC(0-3h) response for patients receiving tiotropium was statistically significant versus placebo, as were the adjusted mean PEFAM and PEFPM responses versus placebo at Week 12:


FEV1 AUC(0-3h)

Response

Adjusted Mean

PEFAM

Adjusted Mean

PEFPM

5 mcg

125 mL

(P = 0.0003)

25.6 L/min

(P < 0.0001)

27.6 L/min

(P < 0.0001)

2.5 mcg

149 mL

(P < 0.0001)

26.3 L/min

(P < 0.0001)

22.4 L/min

(P < 0.0001)

In the study, adjusted mean ACQ­-7 score, measured following treatment at 12 weeks, was similar across all treatment arms:

  • Tiotropium 5 mcg: 1.391
  • Tiotropium 2.5 mcg: 1.438
  • Placebo: 1.377

The incidence of reported adverse events (AEs) was similar across treatment groups: tiotropium 5 mcg, 32.3 percent; tiotropium 2.5 mcg, 31.2 percent; placebo, 29.0 percent.

"We are encouraged by these findings in mild asthma, as they build on previously presented positive results for tiotropium in moderate and severe asthma severities," said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The data from the UniTinA-asthma® clinical trial program presented at AAAAI add to our understanding of tiotropium's potential in asthma patients."

MezzoTinA-Asthma® Data Presented at AAAAI

Using the accepted serum IgE and eosinophil counts as biomarkers for TH2 inflammatory status, TH2-low and TH2-high subgroups were pre-defined in the MezzoTinA-asthma® trials at baseline as total serum IgE ≤ or >430 mcg/L, or blood eosinophils ≤ or >0.6×109/L. Of 2081 patients in the full analysis who received tiotropium or placebo, 1221/1961 were reported with IgE >430 mcg/L and 404/1969 with an eosinophil count of >0.6×109/L.

Both doses of tiotropium had a similar effect on peak and trough FEV1 versus placebo, independent of IgE and eosinophil count:


Adjusted Mean Peak FEV1(0-3h) Response


Subgroup

IgE ≤430 mcg/L

Subgroup

IgE >430 mcg/L

Subgroup

Eosinophils
≤0.6x109L

Subgroup

Eosinophils

>0.6x109L

5 mcg

168 mL

193 mL

170 mL

240 mL

2.5 mcg

197 mL

237 mL

236 mL

176 mL

Trough FEV1 also improved with both doses of tiotropium versus placebo, independently of IgE and eosinophil count:


Adjusted Mean Trough FEV1 Response


Subgroup

IgE ≤430 mcg/L

Subgroup

IgE >430 mcg/L

Subgroup

Eosinophils

≤0.6x109L

Subgroup

Eosinophils

>0.6x109L

5 mcg

139 mL

152 mL

137 mL

182 mL

2.5 mcg

167 mL

188 mL

185 mL

158 mL

In all subgroups, peak FEV1(0–3h) and trough FEV1 responses among patients who received tiotropium were within the same magnitude as responses in the active comparator salmeterol group.

The most frequently reported treatment-emergent AEs in both MezzoTinA-asthma® Phase 3 studies included asthma, PEF rate decrease and nasopharyngitis.

PrimoTinA-Asthma® Data Presented at AAAAI

Of the 912 patients in the PrimoTinA-asthma® trials randomized to receive either tiotropium (n=456) or placebo (n=456) for 48 weeks, 205 reported pre-screening LTRA use, 200 received LTRA at baseline, and 187 had efficacy data at Week 24. Use of LTRAs was permitted during run-in and treatment. Subgroups were defined by pre-screening LTRA use: "Yes"/"No". Mean percent predicted FEV1 at baseline was 55 percent in both groups.


Peak FEV1*

(adjusted mean difference

from placebo)

Trough FEV1**

(adjusted mean difference

from placebo)

LTRA "Yes"

103±51 mL (P = 0.0454)

96±48 mL (P = 0.0442)

LTRA "No"

111±28 mL (P < 0.0001)

91±25 mL (P = 0.0003)

*Peak FEV1 improvements independent of concomitant LTRA use [interaction P = 0.5747]

**Trough FEV1 improvements independent of concomitant LTRA use [interaction P = 0.4639]

The most frequently reported treatment-emergent AEs in both PrimoTinA-asthma® Phase 3 studies included asthma, PEF rate decrease and nasopharyngitis.

About the UniTinA-Asthma® Clinical Trial Program

The comprehensive Phase 3 trial program, UniTinA-asthma®, includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic on current treatment with inhaled corticosteroid (ICS). The program includes over 4,000 patients in more than 150 sites globally. Results from the PrimoTinA-asthma® studies in severe asthma patients were presented at the 2012 European Respiratory Society (ERS) Annual Congress in Vienna, Austria, with additional sub-analyses presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, the 2013 American Thoracic Society (ATS) International Conference, the ERS Annual Congress 2013 and the American College of Chest Physicians (ACCP) Annual Meeting (CHEST 2013). Results from the MezzoTinA-asthma® studies in moderate asthma patients were presented at the ERS Annual Congress 2013.

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, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. 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 make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

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 140 affiliates and more than 46,000 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 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

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

SOURCE Boehringer Ingelheim

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"We are a custom software development, engineering firm. We specialize in cloud applications from helping customers that have on-premise applications migrating to the cloud, to helping customers design brand new apps in the cloud. And we specialize in mobile apps," explained Peter Di Stefano, Vice President of Marketing at Impiger Technologies, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...