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. 2016 Nov 17;4(1):21-33.
doi: 10.15326/jcopdf.4.1.2016.0158.

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

Sanjay Sethi  1 , Charles Fogarty  2 , Nicola A Hanania  3 , Fernando J Martinez  4 , Stephen Rennard  5 , Michael Fries  4 , Chad Orevillo  6 , Patrick Darken  7 , Earl St Rose  8 , Shannon Strom  9 , Tracy Fischer  9 , Michael Golden  9 , Sarvajna Dwivedi  10 , Colin Reisner  6
Affiliations

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

Sanjay Sethi et al. Chronic Obstr Pulm Dis. .

Erratum in

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 (FEV1) area under the curve between 0 and 12 hours (AUC0-12) 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.

Keywords: COPD; Co-Suspension™ Delivery Technology; Foradil®Aerolizer®; bioequivalence; formoterol fumarate; metered dose inhaler; non-inferiority.

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Conflict of interest statement

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.

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