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LATE-BREAKING ABSTRACT: PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD

Klaus Rabe, Fernando Martinez, Roberto Rodriguez-Roisin, Leonardo M. Fabbri, Gary T. Ferguson, Paul Jones, Stephen Rennard, Michael Golden, Patrick Darken, Chad Orevillo, Tracy Fischer, Colin Reisner
European Respiratory Journal 2015 46: PA4363; DOI: 10.1183/13993003.congress-2015.PA4363
Klaus Rabe
1Lungen Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany
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Fernando Martinez
2Department of Internal Medicine, Weill Cornell Medical College, New York, NY United States
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Roberto Rodriguez-Roisin
3Servei de Pneumologia, Institut del Tòrax, Hospital Clinic-IDIBAPS-CIBERES, Barcelona, Spain
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Leonardo M. Fabbri
4Department of Oncology, Haematology and Respiratory Diseases, University of Modena, Modena, Italy
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Gary T. Ferguson
5COPD, Pulmonary Research Institute of Southeast Michigan, Livonia, MI United States
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Paul Jones
6Institute for Infection and Immunity, St. George's, University of London, London, United Kingdom
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Stephen Rennard
7Pulmonary and Critical Care Medicine, University of Nebraska Medical Center, Omaha, NE United States
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Michael Golden
8Clinical Development and Medical Affairs, Pearl Therapeutics Inc., Morristown, NJ United States
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Patrick Darken
8Clinical Development and Medical Affairs, Pearl Therapeutics Inc., Morristown, NJ United States
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Chad Orevillo
8Clinical Development and Medical Affairs, Pearl Therapeutics Inc., Morristown, NJ United States
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Tracy Fischer
8Clinical Development and Medical Affairs, Pearl Therapeutics Inc., Morristown, NJ United States
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Colin Reisner
8Clinical Development and Medical Affairs, Pearl Therapeutics Inc., Morristown, NJ United States
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Abstract

Background: PT003 is a novel co-suspension MDI combination of two long-acting bronchodilators, the LAMA glycopyrronium (GP 14.4µg) and the LABA formoterol fumarate (FF 9.6µg). We investigated the efficacy and safety of PT003 vs individual components PT001 (GP MDI 14.4µg) and PT005 (FF MDI 9.6µg) in patients with moderate to very severe COPD in two Phase 3 studies (PINNACLE-1 and -2).

Methods: In these two randomised, double-blind, placebo-controlled, parallel-group, multicentre studies patients received PT003, PT001, PT005 or placebo, all delivered via co-suspension technology MDI (7:6:6:3) twice-daily for 24 weeks; PINNACLE-1 included open-label tiotropium 18μg once-daily. Primary endpoints were change from baseline in morning trough FEV1 and computerised TDI focal score over 24 weeks.

Results: For trough FEV1, PT003, PT001, and PT005 were superior to placebo and PT003 was superior to PT001 and PT005 (p<0.0001) (table). For TDI focal score, variable results were obtained for PT001 and PT005 vs placebo. PT003 provided benefit vs placebo (p≤0.0041) and PT001 (p≤0.0199) in both studies, and vs PT005 in PINNACLE-2 (p=0.0028) with a smaller benefit in PINNACLE-1 (p=0.1060). There were no unexpected safety findings.

Conclusion: The results from PINNACLE-1 and -2 support the overall efficacy of PT003 (GP 14.4µg/FF 9.6µg MDI) as a bronchodilator therapy for patients with COPD.

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LATE-BREAKING ABSTRACT: PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD
Klaus Rabe, Fernando Martinez, Roberto Rodriguez-Roisin, Leonardo M. Fabbri, Gary T. Ferguson, Paul Jones, Stephen Rennard, Michael Golden, Patrick Darken, Chad Orevillo, Tracy Fischer, Colin Reisner
European Respiratory Journal Sep 2015, 46 (suppl 59) PA4363; DOI: 10.1183/13993003.congress-2015.PA4363

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LATE-BREAKING ABSTRACT: PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD
Klaus Rabe, Fernando Martinez, Roberto Rodriguez-Roisin, Leonardo M. Fabbri, Gary T. Ferguson, Paul Jones, Stephen Rennard, Michael Golden, Patrick Darken, Chad Orevillo, Tracy Fischer, Colin Reisner
European Respiratory Journal Sep 2015, 46 (suppl 59) PA4363; DOI: 10.1183/13993003.congress-2015.PA4363
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