Biomaterial Database

Aclidinium/formoterol fixed-dose combination for the treatment of chronic obstructive pulmonary disease. 2015

M Cazzola, and L Calzetta, and M G Matera

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.

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.

UI	MeSH Term	Description	Entries
D011788	Quality of Life	A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.	HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004338	Drug Combinations	Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.	Drug Combination,Combination, Drug,Combinations, Drug
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068759	Formoterol Fumarate	An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.	3-Formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate,Arformoterol,BD 40A,Eformoterol,Foradil,Formoterol,Formoterol Fumarate, ((R,R)-(+-))-isomer,Formoterol, ((R,R)-(+-))-isomer,Oxis
D014326	Tropanes	N-methyl-8-azabicyclo[3.2.1]octanes best known for the ones found in PLANTS.	Azabicyclo(3.2.1)Octanes
D029424	Pulmonary Disease, Chronic Obstructive	A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.	Airflow Obstruction, Chronic,COAD,COPD,Chronic Airflow Obstruction,Chronic Obstructive Airway Disease,Chronic Obstructive Lung Disease,Chronic Obstructive Pulmonary Disease,Chronic Obstructive Pulmonary Diseases,Airflow Obstructions, Chronic,Chronic Airflow Obstructions