title: Aclidinium/formoterol fixed-dose combination for the treatment of chronic obstructive pulmonary disease.
abstract: This review will be focused on the development of aclidinium bromide/formoterol fumarate (ACLI/FORM) fixed-dose combinations (FDC) that have been granted marketing authorization by the European Commission to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). ACLI/FORM FDC has been studied in 2 pivotal trials involving over 3,400 patients with COPD, in which it was compared with ACLI alone, FORM alone and placebo. The addition of FORM to ACLI resulted in greater bronchodilation than FORM or ACLI alone. ACLI/FORM FDC was also shown to increase the percentage of patients who had an improvement in symptoms and health-related quality of life compared with monotherapies. The frequency of side effects reported with ACLI/FORM FDC was low and their nature did not raise any major safety concern.
authors.affiliation: Division of Respiratory Medicine, University Hospital Tor Vergata; Unit of Respiratory Clinical Pharmacology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. mario.cazzola@uniroma2.it.
authors.forename: M
authors.initials: M
authors.lastname: Cazzola
authors.affiliation: Unit of Respiratory Clinical Pharmacology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Calzetta
authors.affiliation: Centre of Excellence for Cardiovascular Diseases, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", Second University of Naples, Naples, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Matera
mesh_terms: D002986:Clinical Trials as Topic; D004338:Drug Combinations; D000068759:Formoterol Fumarate / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D014326:Tropanes / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology
chemical_list: D004338:Drug Combinations; D014326:Tropanes; C542859:aclidinium bromide; D000068759:Formoterol Fumarate
keywords: COPD; Chronic obstructive pulmonary disease; FEV1; Formoterol/aclidinium; LABA; LAMA