Biomaterial Database

Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD. 2023

Susan Muiser, and Kai Imkamp, and Dianne Seigers, and Nynke J Halbersma, and Judith M Vonk, and Bart H D Luijk, and Gert-Jan Braunstahl, and Jan-Willem van den Berg, and Bart-Jan Kroesen, and Janwillem W H Kocks, and Irene H Heijink, and Helen K Reddel, and Huib A M Kerstjens, and Maarten van den Berge

Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands s.muiser@umcg.nl.

Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety.

UI	MeSH Term	Description	Entries
D001993	Bronchodilator Agents	Agents that cause an increase in the expansion of a bronchus or bronchial tubes.	Bronchial-Dilating Agents,Bronchodilator,Bronchodilator Agent,Broncholytic Agent,Bronchodilator Effect,Bronchodilator Effects,Bronchodilators,Broncholytic Agents,Broncholytic Effect,Broncholytic Effects,Agent, Bronchodilator,Agent, Broncholytic,Agents, Bronchial-Dilating,Agents, Bronchodilator,Agents, Broncholytic,Bronchial Dilating Agents,Effect, Bronchodilator,Effect, Broncholytic,Effects, Bronchodilator,Effects, Broncholytic
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
D004983	Ethanolamines	AMINO ALCOHOLS containing the ETHANOLAMINE; (-NH2CH2CHOH) group and its derivatives.	Aminoethanols
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068297	Fluticasone-Salmeterol Drug Combination	A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.	Advair,Advair Diskus,Advair HFA,Fluticasone - Salmeterol,Fluticasone Propionate - Salmeterol,Fluticasone Propionate - Salmeterol Combination,Fluticasone Propionate - Salmeterol Xinafoate,Fluticasone Propionate, Salmeterol Xinafoate Drug Combination,Fluticasone Propionate-Salmeterol Drug Combination,Fluticasone Propionate-Salmeterol Xinafoate Combination,Fluticasone Propionate-Salmeterol Xinafoate Drug Combination,Fluticasone-Salmeterol Combination,Seretide,Combination, Fluticasone-Salmeterol,Drug Combination, Fluticasone-Salmeterol,Fluticasone Propionate Salmeterol,Fluticasone Propionate Salmeterol Combination,Fluticasone Propionate Salmeterol Drug Combination,Fluticasone Propionate Salmeterol Xinafoate,Fluticasone Propionate Salmeterol Xinafoate Combination,Fluticasone Propionate Salmeterol Xinafoate Drug Combination,Fluticasone Salmeterol,Fluticasone Salmeterol Combination,Fluticasone Salmeterol Drug Combination
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
D000069502	Budesonide, Formoterol Fumarate Drug Combination	A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.	Budesonide Formoterol Drug Combination,Budesonide Formoterol Fumarate Drug Combination,Budesonide-Formoterol Drug Combination,Budesonide-Formoterol Fumarate Drug Combination,Symbicort,Combination, Budesonide-Formoterol Drug,Drug Combination, Budesonide-Formoterol
D000305	Adrenal Cortex Hormones	HORMONES produced by the ADRENAL CORTEX, including both steroid and peptide hormones. The major hormones produced are HYDROCORTISONE and ALDOSTERONE.	Adrenal Cortex Hormone,Corticoid,Corticoids,Corticosteroid,Corticosteroids,Cortex Hormone, Adrenal,Hormone, Adrenal Cortex,Hormones, Adrenal Cortex
D000730	Androstadienes	Derivatives of the steroid androstane having two double bonds at any site in any of the rings.
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes