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Novartis’ Ultibro® Breezhaler® improved lung function and COPD symptoms after direct switch from previous treatment

Ultibro^® Breezhaler^®improved lung function and breathlessness after direct switch from long-acting bronchodilators or steroid-containing combination therapies

Results further support the 2017 GOLD recommendations that dual bronchodilation should be the foundation treatment for the majority of symptomatic COPD patients
Data from the pragmatic CRYSTAL study showcased for the first time at the 2016 British Thoracic Society Winter Meeting in London, UK

December 8, 2016 Novartis Basel

Novartis today announced positive results from the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments, including steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro^® Breezhaler^®(indacaterol/glycopyrronium) 110/50 mcg.

In the CRYSTAL study, patients with moderate COPD who were switched to Ultibro Breezhaler from their previous therapy (LABA+ICS^* or LABA or LAMA***) experienced superior improvements in lung function (trough FEV₁) and breathlessness**** at week 12 (p<0.0001). Significantly, CRYSTAL is the first LABA/LAMA pragmatic trial, designed to mimic clinical practice, so treatment switching occurred without a washout period[1].

“Today’s results are significant as they show for the first time the positive effect of directly switching to Ultibro Breezhaler from other COPD treatments, such as inhaled steroid-containing combination therapies,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “By showing that improved symptom control can be achieved through using Ultibro Breezhaler, the CRYSTAL study provides further support to limit the use of inhaled steroid-containing therapies to specific patient types that really need it.”

Ultibro Breezhaler was also well tolerated in the CRYSTAL study[1].

About CRYSTAL
CRYSTAL was a prospective, multicenter, 12-week, randomized, pragmatic, open-label trial. Patients were recruited into four groups according to previous medication and symptoms, and randomized to a direct switch to Seebri^® Breezhaler^®(glycopyrronium) 50 mcg or Ultibro^® Breezhaler^®(indacaterol/glycopyrronium)110/50 mcg once daily vs. continuation of previous treatment. The study enrolled a total of 4,389 symptomatic, non-frequently exacerbating (up to one exacerbation in the previous year) patients with moderate COPD and 2,159 patients received Ultibro Breezhaler or continued their baseline therapy. The Seebri Breezhaler treatment arms of the study were underpowered due to sample size.

Co-primary objectives of the study were:

Superiority of Ultibro Breezhaler vs. LABA, LAMA and LABA+ICS in terms of improvement of lung function (trough FEV₁) and breathlessness (transition dyspnoea index) at week 12.
Superiority of Seebri Breezhaler vs. previous SABA and/or SAMA^§ treatment in terms of improvement of lung function (trough FEV₁) and breathlessness (transition dyspnoea index) at week 12
Non-inferiority of Seebri Breezhaler vs. previous LABA or LAMA treatment in terms of improvement of lung function (trough FEV₁) and breathlessness (transition dyspnoea index) at week 12.

About Ultibro Breezhaler
Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg is a once-daily LABA/LAMA dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[2]. 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 mcg[3]-[5] and open-label tiotropium (18 mcg). Ultibro Breezhaler is also currently the only steroid-free treatment to offer prescribers clinically proven superiority over the most prescribed ICS/LABA combination^** in preventing COPD exacerbations[6]. Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

References
[1] Vogelmeier C, Aalamian-Mattheis M, Greulich T, et al. Efficacy and safety of the direct switch from various previous treatments to glycopyrronium or indacaterol/glycopyrronium in patients with moderate COPD: The CRYSTAL Study. Abstract presented at the British Thoracic Society Winter Meeting: 6 December 2016
[2] Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf(link is external) [Accessed 21 November 2016].
[3] Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].
[4] Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].
[5] Banerji D, et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30].
[6] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385(link is external) [Accessed 21 November 2016].
[7] Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 19-Oct-2016. Available at: http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation
+Powder,+Hard+Capsules+44mcg/(link is external) [Accessed 21 November 2016].
[8] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26; 11:2527-2533.
[9] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/(link is external) [Accessed 21 November 2016].
[10] World Health Organization: The top 10 causes of death fact sheet N^o 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/(link is external) [Accessed 21 November 2016].
[11] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. Available at: http://goldcopd.org/(link is external) [Accessed 21 November 2016].