- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Novartis announces new trial results for Ultibro Breezhaler in COPD
17 November 2015 • Author: Victoria White
Novartis has announced positive first results from the Phase III FLAME head-to-head trial examining Ultibro Breezhaler (indacaterol/glycopyrronium) in chronic obstructive pulmonary disease (COPD).
Once-daily Ultibro Breezhaler met its primary endpoint (non-inferiority) and also demonstrated superiority to twice-daily Seretide (salmeterol/fluticasone) in reducing the rate of all COPD exacerbations over one year of treatment.
Novartis says this finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.
Results may support expanding the use of dual bronchodilators
“Today’s FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients.”
FLAME is the last of 11 studies in the IGNITE Phase III clinical trial programme exploring Ultibro Breezhaler for the treatment of COPD. Ultibro Breezhaler is currently approved for use in over 70 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. In the US the treatment is approved in a twice-daily formulation of indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg, known as Utibron Neohaler.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics