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      Efficacy of Formoterol Fumarate Delivered by Metered Dose Inhaler Using Co-Suspension™ Delivery Technology Versus Foradil® Aerolizer® in Moderate-To-Severe COPD: A Randomized, Dose-Ranging Study

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          Abstract

          Background: Co-Suspension™ Delivery Technology offers a novel pharmaceutical platform for inhaled drug therapy. This randomized, double-blind, placebo-controlled, single-dose study (NCT01349868) evaluated the efficacy of a range of doses for formoterol fumarate (FF) delivered using Co-Suspension delivery technology via a pressurized metered dose inhaler (MDI) versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Secondary objectives included determination of non-inferior efficacy and systemic exposure compared with open-label Foradil ® 12 μg (Foradil ® Aerolizer ®; formoterol fumarate dry powder inhaler).

          Methods: Patients received each of the 6 study treatments (FF MDI [7.2, 9.6 and 19.2μg], placebo MDI and open-label Foradil ® [12 and 24µg]), separated by 3–10 days. Spirometry was performed 60 and 30 minutes prior to and at regular intervals up to 12 hours post-administration of study drug. The primary outcome measure was the change in forced expiratory volume in 1 second (FEV 1) area under the curve between 0 and 12 hours (AUC 0-12) relative to test day baseline.

          Results: A total of 50 patients were randomized to study treatment sequences. All doses of FF MDI demonstrated superiority to placebo ( p<0.0001) and non-inferiority to Foradil ® 12μg, on bronchodilator outcome measures. No serious adverse events were reported during the study.

          Conclusions: This study demonstrates non-inferiority of bronchodilator response and bioequivalent exposure of FF MDI 9.6μg to Foradil ® 12μg, with both agents exhibiting a similar safety profile in patients with moderate-to-severe COPD. This study supports the selection of FF MDI 9.6µg for further evaluation in Phase III trials.

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          Author and article information

          Journal
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
          COPD Foundation Inc (Miami, USA )
          2372-952X
          2017
          17 November 2016
          : 4
          : 1
          : 21-33
          Affiliations
          [1]Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo
          [2]Spartanburg Medical Research, Spartanburg, South Carolina
          [3]Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, Texas
          [4]Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York
          [5]Clinical Discovery Unit, AstraZeneca, Cambridge, Cambridgeshire, United Kingdom
          [6]Clinical Development, Pearl Therapeutics Inc., Morristown, New Jersey
          [7]Biostatistics, Pearl Therapeutics Inc., Morristown, New Jersey
          [8]Clinical Operations, Pearl Therapeutics Inc., Morristown, New Jersey
          [9]Regulatory Affairs, Pearl Therapeutics Inc., Durham, North Carolina
          [10]Pearl Therapeutics Inc., Redwood City, California
          Author notes
          [ Address correspondence to: Sanjay Sethi, MD ] 001 716 862 7875 ssethi@ 123456buffalo.edu

          The authors would like to thank all of the patients and their families, the team of investigators, research nurses and operations staff involved in this study. The authors would also like to thank Everest Clinical Research, who performed the statistical analyses for this study, funded by Pearl Therapeutics, Inc. a member of the AstraZeneca group. Medical writing/editorial support was provided by Catherine Stanton of Complete Medical Communications, funded by Pearl Therapeutics, Inc., a member of the AstraZeneca Group. Co-Suspension is a trademark of the AstraZeneca group of companies. Principal investigators: Charles M. Fogarty, Leonard Dunn, Jack Parrino.

          SSethi has received grants from AstraZeneca, Dey, and Pearl Therapeutics, Inc. He has received personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Cempra, CSL Behring, Forest, GlaxoSmithKline, Merck, Pearl Therapeutics Inc., Pulmonx, Reckitt Benckiser, Sunovion, and Theravance. CF is a consultant and investigator for Pearl Therapeutics, Inc. NAH has served as a consultant and received honoraria from Pearl and Astra Zeneca. His institution has received research grant support on his behalf to conduct clinical trials.

          FJM has participated in steering committees on COPD or idiopathic pulmonary fibrosis sponsored by Bayer, Centocor, Forest, Gilead, Janssen, GlaxoSmithKline, Nycomed/Takeda and Promedior. He has participated in advisory boards for COPD or idiopathic pulmonary fibrosis for Actelion, Amgen, AstraZeneca, Boehringer Ingelheim, Carden Jennings, CSA Medical, Ikaria, Forest, Genentech, GlaxoSmithKline, Janssen, Merck, Pearl, Nycomed/Takeda, Pfizer, Roche, Sudler & Hennessey, Veracyte, and Vertex. He has prepared or presented continuing medical presentations on COPD or idiopathic pulmonary fibrosis for the American College of Chest Physicians, the American Thoracic Society, CME Incite, Center for Health Care Education, Inova Health Systems, MedScape, Miller Medical, National Association for Continuing Education, Paradigm, Peer Voice, Projects in Knowledge, Spectrum Health System, St. John’s Hospital, St. Mary’s Hospital, University of Illinois-Chicago, University of Texas Southwestern, University of Virginia, UpToDate, and Wayne State University. FJM has participated in data safety monitoring committees sponsored by GlaxoSmithKline and Stromedix. He has assisted with Food and Drug Administration presentations sponsored by Boehringer Ingelheim, GlaxoSmithKline, and Ikaria. He has spoken on COPD for Bayer, Forest, GlaxoSmithKline, and Nycomed/Takeda. He has participated in advisory teleconferences sponsored by the American Institute for Research, Axon, Grey Healthcare, Johnson & Johnson, and Merion. He has received book royalties from Informa. SR is an employee of AstraZeneca PLC. CO, PD, ES, SStrom, TF, MG, SD and CR are employees of Pearl Therapeutics, Inc.

          Article
          PMC5560247 PMC5560247 5560247
          10.15326/jcopdf.4.1.2016.0158
          5560247
          28848908
          5f5e0ec0-bdeb-487a-abdc-e7b9c03bc8ce
          JCOPDF © 2017
          History
          : 6 September 2016
          Funding
          This study was funded by Pearl Therapeutics Inc., a member of the AstraZeneca Group.
          Categories
          Original Research

          bioequivalence,formoterol fumarate,metered dose inhaler,Foradil®Aerolizer®,COPD,non-inferiority,Co-Suspension™ Delivery Technology

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