Welcome!

News Feed Item

Mundipharma Commences COPD Trial

CAMBRIDGE, England, September 19, 2013 /PRNewswire/ --

Mundipharma Research Limited (Mundipharma) announced today a major milestone in the development programme of flutiform® (fluticasone propionate / formoterol fumarate) for the treatment of Chronic Obstructive Pulmonary Disease (COPD) with the commencement of a key clinical trial. COPD is a life-threatening lung disease that interferes with normal breathing, estimated to affect at least 64 million people worldwide[1].   The first patient in the trial is expected to start treatment with flutiform this month.

The Effect (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) study has been designed to investigate the superiority of flutiform 250/10 μg (2 puffs bid) and flutiform 125/5 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations over the 52-week treatment period.

"flutiform has already been approved as a maintenance therapy for asthma in adults and adolescents. We're excited with the progress that we've made to date with this combination and we believe that it also has the potential to be an important new treatment option for patients suffering from COPD," commented Prof.Dr. Karen Reimer, Managing Director, Mundipharma Research Limited.

This is the first large scale COPD study to evaluate two different doses of an ICS (Inhaled Corticosteroid) / LABA (Long-Acting Beta Agonist) combination, where the dose of both components is adjusted. The study will include recently developed COPD assessment tools which may further our understanding of this disease and will also evaluate serum biomarkers relevant to this multisystem disease. The study will provide useful new insights for clinicians into the management and assessment of COPD.

"The Mundipharma network of independent associated companies is committed to expanding our product offering in respiratory diseases including COPD, a chronic and debilitating disease which is predicted to become the third leading cause of death worldwide by 2030," added Georg Toufar, Chief Marketing Officer, Mundipharma International Ltd.

Study design

The primary objective of the Effect study is to show superiority in the efficacy of fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations during the 52-week treatment period.

The study is a Phase III multi-centre, randomised, double-blind and double dummy, placebo and active-controlled, parallel-group study comparing fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) and fluticasone propionate / formoterol fumarate  125/5 μg (2 puffs bid) versus formoterol fumarate dihydrate 12 μg (1 puff bid) in subjects with COPD.

Approximately 1,530 patients will be randomised in order to achieve 510 patients in each treatment group stratified for FEV1 % predicted category at baseline (FEV1 < 30% predicted, or 30-50 % predicted) and number of exacerbations in the previous year (≥ 2 or < 2).

Patients from approximately 15-20 countries will participate in the trial, including Bulgaria, Czech Republic, Germany, Hungary, Latvia, Macedonia, Poland, Romania, the Russian Federation, Slovakia, South Africa, South Korea, Spain, Ukraine and the United Kingdom.

flutiform is not currently licensed for the treatment of COPD

Notes to editors:

About flutiform

flutiform is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting β2-agonist (LABA) formoterol fumarate in a single aerosol.

In Europe, flutiform is indicated for adults and adolescents (aged ≥12 years) with asthma that is either not adequately controlled with an ICS plus an as-needed short-acting β2-agonist, or is already adequately controlled with an ICS plus LABA.

flutiform has been approved for the treatment of asthma in 21 European countries and is commercially available in 12: Germany, the UK, Italy, Belgium, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway, Slovakia and Sweden.  Further launches are anticipated during 2013/14.

About COPD

Chronic Obstructive Pulmonary Disease (COPD) - also called emphysema and/or chronic obstructive bronchitis - is a preventable lung disease caused by the long-term inhalation of pollutants, most commonly cigarette smoke, that progressively and permanently reduces the ability of adults to breathe well and maintain active lives. COPD is characterised by breathlessness (or dyspnoea), coughing, wheezing and increased sputum (mucus or phlegm) production. These symptoms, in particular shortness of breath, can restrict a patient's ability to perform normal daily activities.[2]

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. These independent associated companies are known as Napp in the UK and Norpharma in Denmark.  For further information please visit: http://www.mundipharma.com.

About Skyepharma

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products.  The Group is eligible for revenues from 14 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses.  The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies.  For more information, visit http://www.skyepharma.com

Mundipharma International Corporation Limited is licensed by Jagotec AG, a Skyepharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas. flutiform is a registered trade mark of Jagotec AG.

References:

  1. World Health Organisation. http://www.who.int/respiratory/copd/en/ (Accessed Sept 2013)
  2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. (Accessed: Sept 2013).

ZINC code: MINT FL-13049
Date of preparation: September 2013

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
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time t...
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...
CloudEXPO New York 2018, colocated with DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
Cell networks have the advantage of long-range communications, reaching an estimated 90% of the world. But cell networks such as 2G, 3G and LTE consume lots of power and were designed for connecting people. They are not optimized for low- or battery-powered devices or for IoT applications with infrequently transmitted data. Cell IoT modules that support narrow-band IoT and 4G cell networks will enable cell connectivity, device management, and app enablement for low-power wide-area network IoT. B...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term.
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Transformation Abstract Encryption and privacy in the cloud is a daunting yet essential task for both security practitioners and application developers, especially as applications continue moving to the cloud at an exponential rate. What are some best practices and processes for enterprises to follow that balance both security and ease of use requirements? What technologies are available to empower enterprises with code, data and key protection from cloud providers, system administrators, inside...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Nicolas Fierro is CEO of MIMIR Blockchain Solutions. He is a programmer, technologist, and operations dev who has worked with Ethereum and blockchain since 2014. His knowledge in blockchain dates to when he performed dev ops services to the Ethereum Foundation as one the privileged few developers to work with the original core team in Switzerland.