A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations.
Combination inhalers containing corticosteroids and long-acting β-agonists are used to reduce exacerbation rates in patients with severe chronic obstructive pulmonary disease (COPD). The FORWARD (Foster 48-week Trial to Reduce Exacerbations in COPD) clinical trial in severe COPD patients is a comparison of extrafine beclomethasone dipropionate and formoterol in a combination inhaler with extrafine formoterol; the co-primary end-points are exacerbation rates over 48 weeks and improvement in forced expiratory volume in 1 s over 12 weeks. The traditional physician diagnosis of exacerbations is a co-primary outcome, and the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) means of collecting patient-reported outcome data are also being used to enhance the detection of exacerbation events. EXACT data are being collected using a novel application of a digital platform technology. FORWARD is therefore expected to provide information on the ability of EXACT to detect and measure exacerbations in a large clinical trial setting. The study design of FORWARD is described in this article.
University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK. dsingh@meu.org.uk
Dave
D
Singh
Jorg
J
Kampschulte
Jadwiga A
JA
Wedzicha
Paul W
PW
Jones
Géraldine
G
Cohuet
Massimo
M
Corradi
Tim
T
Higenbottam
Stefano
S
Petruzzelli
Jørgen
J
Vestbo
D001507:Beclomethasone / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D000068759:Formoterol Fumarate; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000188:drug therapy*; D057566:Self Report
D001993:Bronchodilator Agents; D004983:Ethanolamines; D001507:Beclomethasone; D000068759:Formoterol Fumarate