title: Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study.
abstract: The efficacy and safety of twice-daily aclidinium bromide/formoterol fumarate was compared with that of salmeterol/fluticasone propionate in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD).AFFIRM COPD (Aclidinium and Formoterol Findings in Respiratory Medicine COPD) was a 24-week, double-blind, double-dummy, active-controlled study. Patients were randomised (1:1) to aclidinium/formoterol 400/12 µg twice-daily via Genuair/Pressair or salmeterol/fluticasone 50/500 µg twice-daily via Accuhaler. The primary end-point was peak forced expiratory volume in 1 s (FEV1) at week 24. Other end-points included Transition Dyspnoea Index (TDI) focal score at week 24, TDI and St George's Respiratory Questionnaire (SGRQ) responders, COPD Assessment Test and SGRQ scores, assessment of COPD symptoms and exacerbations, use of reliever medication, and device preference. Adverse events were monitored throughout.In total, 933 patients were eligible (mean age 63.4 years, 65.1% male). Aclidinium/formoterol was superior to salmeterol/fluticasone in peak FEV1and noninferior in TDI. Health status and reduction in exacerbation risk were similar in both groups. While both treatments were well tolerated, pneumonia occurred less frequently with aclidinium/formoterol than salmeterol/fluticasone.In stable COPD, aclidinium/formoterol significantly improved bronchodilation versus salmeterol/fluticasone, with equivalent benefits in symptom control and reduction in exacerbation risk. Both treatments were well tolerated and treatment-related adverse events were less common with aclidinium/formoterol.
authors: Dept of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Member of the German Center for Lung Research (DZL), Philipps-University Marburg, Marburg, Germany claus.vogelmeier@med.uni-marburg.de.
authors: Claus
authors: C
authors: Vogelmeier
authors: Respiratory Pathophysiology, University Hospital of Pisa, Pisa, Italy.
authors: Pier Luigi
authors: PL
authors: Paggiaro
authors: Hospital Universitari de Bellvitge, University of Barcelona, and Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.
authors: Jordi
authors: J
authors: Dorca
authors: 2nd Dept of Respiratory Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland.
authors: Pawel
authors: P
authors: Sliwinski
authors: Moncton Respirology Clinic, Moncton, NB, Canada.
authors: Marcel
authors: M
authors: Mallet
authors: Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the Germany Center for Lung Research (DZL), Grosshansdorf, Germany.
authors: Anne-Marie
authors: AM
authors: Kirsten
authors: insaf Respiratory Research Institute, Wiesbaden, Germany.
authors: Jutta
authors: J
authors: Beier
authors: AstraZeneca, Barcelona, Spain.
authors: Beatriz
authors: B
authors: Seoane
authors: AstraZeneca, Barcelona, Spain.
authors: Rosa Maria
authors: RM
authors: Segarra
authors: Almirall SA, Barcelona, Spain.
authors: Anne
authors: A
authors: Leselbaum
mesh_terms: D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000494:pharmacology; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage*; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D015272:Pulmonary Medicine; D000068299:Salmeterol Xinafoate / Q000008:administration & dosage; D012907:Smoking; D013147:Spirometry; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014326:Tropanes / Q000008:administration & dosage*
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination; D014326:Tropanes; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C542859:aclidinium bromide; D000068759:Formoterol Fumarate