• Feature

    1. Prof Wedzicha Discusses COPD, Dual Bronchodilation and SPARK Study

    2. COPD Patients and Everyday Activities

  • Media

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      Photo:

      Chronic Obstructive Pulmonary Disease Infographic

      See below for PDF version

    2. NoImage
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      IGNITE Clinical Trial Program Infographic

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      LANTERN Study Infographic

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      Dual Bronchodilation Infographic

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  • Related Documents

    1. Chronic Obstructive Pulmonary Disease Infographic

    2. IGNITE Clinical Trial Program Infographic

    3. LANTERN Study Infographic

    4. Dual Bronchodilation Infographic

  • Sep 07, 2014 12:55 PM RST

    Novartis data at ERS 2014 show once-daily Ultibro® Breezhaler® is superior in reducing COPD flare ups compared to Seretide®*

  • ·  Once-daily Ultibro® Breezhaler®  reduced exacerbations (flare ups) by 31% compared to twice-daily Seretide® Accuhaler®* in moderate-to-severe COPD patients1

    ·  LANTERN study further confirmed superiority of Ultibro Breezhaler in improving lung function compared to Seretide® in moderate-to-severe COPD patients1

    ·  First presentation of LANTERN trial at European Respiratory Society International Congress involving over 700 COPD patients1


    Basel, September 7, 2014 Novartis today presented new data that demonstrated once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) was superior in reducing exacerbations (flare ups) and improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone (SFC)), in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). These findings from the head-to-head LANTERN study were presented for the first time at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany.

    The LANTERN study showed Ultibro Breezhaler significantly reduced the rate of moderate-to-severe exacerbations by 31% compared to SFC1, in moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. In addition, Ultibro Breezhaler patients had significantly increased lung function (trough FEV1 0.075 L (p<0.001); AUC0-4h 0.122 L (p<0.001)), as compared to SFC after 26 weeks of treatment. The safety profile of Ultibro Breezhaler was comparable to SFC1.

    “These new results from LANTERN provide further evidence of the potential of Ultibro Breezhaler to deliver better exacerbation reduction and improvements in lung function, compared to the current standard of care,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals1,2.  

    The new findings from LANTERN support the use of Ultibro Breezhaler as an alternative steroid-free treatment to SFC in moderate-to-severe COPD patients1. This approach is consistent with the Global Initiative for Chronic Obstructive Lung Disease 2014 guidelines3.

    COPD symptoms can have a major negative impact on a patient’s ability to breathe and function, reducing their quality of life3,4. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens5. There is a need for newer treatment options in COPD because many patients remain symptomatic despite medical therapy6

    About LANTERN
    LANTERN was a randomized, double-blind, parallel-group, 26-week study involving 744 patients and conducted at 56 sites across China, Argentina, Chile and Taiwan7. The primary objective of the study was to demonstrate the non-inferiority of Ultibro Breezhaler 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year1. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. In this study, exacerbations were a pre-specified exploratory endpoint.

    About Ultibro Breezhaler
    Ultibro Breezhaler is a once-daily dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD2. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg8-10 and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 40 countries, including countries within the EU, Japan, Canada, countries within Latin America and Australia.

    About the Novartis COPD portfolio
    Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro Breezhaler (indacaterol/ glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler®/ArcaptaTM NeohalerTM (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

    Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation11. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly2,11.

    About COPD
    COPD affects an estimated 210 million people worldwide12 and is projected to be the third leading cause of death by 20203. It is progressive (usually gets worse over time), and can be a life-threatening disease3,12. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life3,12. It is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation13,14.

  • Full Press Release

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.


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