Click here to close now.

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
Countless business models have spawned from the IaaS industry. Resell Web hosting, blogs, public cloud, and on and on. With the overwhelming amount of tools available to us, it's sometimes easy to overlook that many of them are just new skins of resources we've had for a long time. In his General Session at 16th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, broke down what we've got to work with and discuss the benefits and pitfalls to discover how we can best use them to d...
"We have seen the evolution of WebRTC right from the starting point to what it has become today, that people are using in real applications," noted Dr. Natasha Tamaskar, Vice President and Head of Cloud and Mobile Strategy and Ecosystem at GENBAND, in this SYS-CON.tv interview at WebRTC Summit, held June 9-11, 2015, at the Javits Center in New York City.
Enterprises are turning to the hybrid cloud to drive greater scalability and cost-effectiveness. But enterprises should beware as the definition of “policy” varies wildly. Some say it’s the ability to control the resources apps’ use or where the apps run. Others view policy as governing the permissions and delivering security. Policy is all of that and more. In his session at 16th Cloud Expo, Derek Collison, founder and CEO of Apcera, explained what policy is, he showed how policy should be arch...
The 3rd International WebRTC Summit, to be held Nov. 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 15th International Cloud Expo, 6th International Big Data Expo, 3rd International DevOps Summit and 2nd Internet of @ThingsExpo. WebRTC (Web-based Real-Time Com...
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, discussed how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at th...
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world...
SYS-CON Events announced today that Harbinger Systems will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Harbinger Systems is a global company providing software technology services. Since 1990, Harbinger has developed a strong customer base worldwide. Its customers include software product companies ranging from hi-tech start-ups in Silicon Valley to leading product companies in the US a...
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
"CenturyLink brings a full suite of services to the table and that enables us to be an IT service provider," explained Jeff Katzen, Director of the Cloud Practice at CenturyLink, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises ar...
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.