title: Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations.
abstract: The FORWARD study is a randomised, double-blind trial that compares the efficacy and safety of 48 weeks treatment with extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI, 2 inhalations BID, vs. FOR 12 μg pMDI, 1 inhalation BID, in severe COPD patients with a history of exacerbations. Co-primary endpoints were exacerbation rate over 48 weeks and pre-dose morning FEV(1) at 12 weeks. The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV(1) 42% predicted). Salbutamol as rescue therapy, theophylline and tiotropium (if stable regimen prior to screening) were allowed. Compared to FOR, BDP/FOR: (1) reduced the exacerbation rate (rate ratio: 0.72 [95% confidence interval 0.62-0.84], p < 0.001); (2) improved pre-dose morning FEV(1) (mean difference: 0.069 L [0.043-0.095] p < 0.001); (3) prolonged the time to first exacerbation; (4) improved the SGRQ total score. The percentage of patients with adverse events was similar (52.1% with BDP/FOR and 49.2% with FOR). Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs. Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone.
authors: National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: j.wedzicha@imperial.ac.uk.
authors: J A
authors: JA
authors: Wedzicha
authors: Medicines Evaluation Unit, South Manchester University Hospital, Manchester, United Kingdom.
authors: D
authors: D
authors: Singh
authors: Respiratory & Allergy Research Group, Manchester Academic Health Sciences Centre, South Manchester University Hospital, Manchester, United Kingdom.
authors: J
authors: J
authors: Vestbo
authors: Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Italy.
authors: P L
authors: PL
authors: Paggiaro
authors: Clinical Science, St. George's University of London, United Kingdom.
authors: P W
authors: PW
authors: Jones
authors: Chiesi Farmaceutici, Courbevoie, France.
authors: F
authors: F
authors: Bonnet-Gonod
authors: Chiesi Farmaceutici, Courbevoie, France.
authors: G
authors: G
authors: Cohuet
authors: Department of Clinical and Experimental Medicine, University of Parma, Italy.
authors: M
authors: M
authors: Corradi
authors: Chiesi Farmaceutici, Parma, Italy.
authors: S
authors: S
authors: Vezzoli
authors: Chiesi Farmaceutici, Parma, Italy.
authors: S
authors: S
authors: Petruzzelli
authors: Institut del Tòrax, Hospital Clinic, Univ. Barcelona, Spain.
authors: A
authors: A
authors: Agusti
mesh_terms: D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012621:Seasons; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D005938:Glucocorticoids; D001507:Beclomethasone; D000068759:Formoterol Fumarate
keywords: COPD; Exacerbation; Extrafine; Inhaled steroids; Long acting bronchodilators; Patient reported outcomes