TY - JOUR T1 - Prognosis of patients with COPD not eligible for major clinical trials JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2022.2376 VL - 60 IS - suppl 66 SP - 2376 AU - Y Çolak AU - B G Nordestgaard AU - P Lange AU - J Vestbo AU - S Afzal Y1 - 2022/09/04 UR - http://erj.ersjournals.com/content/60/suppl_66/2376.abstract N2 - Introduction: Randomised controlled trials only include a subset of patients with COPD fulfilling strict inclusion criteria. Thus, most patients with COPD do not have the necessary evidence to support treatment effectiveness.Objective: To test the hypothesis that most individuals with COPD in the general population are not represented in major clinical trials despite clinically significant disease with exacerbations and early death.Methods: In 105,630 adults from a Danish contemporary population-based cohort, we defined COPD as age≥40 years, chronic respiratory symptoms, history of smoking exposure, and airflow limitation with FEV1/FVC<0.70. Outcomes included acute exacerbations and all-cause mortality. Symptomatic smokers without COPD were used as a reference group.Results: 7,516(7%) and 16,079(15%) were symptomatic smokers with and without COPD. Only 44% of those with COPD were eligible for major clinical trials when applying FEV1<80% predicted, smoking history≥10 pack-years, and no comorbid asthma as inclusion criteria. During median 8.9 years follow-up, we observed 2,130 acute exacerbations and 3,973 deaths in symptomatic smokers. Compared to symptomatic smokers without COPD, multivariable adjusted hazard ratios(HRs) for exacerbations were 7.45(95% CI:5.41-10.3) and 29.0(21.1-39.8) in those with COPD respectively excluded and eligible for clinical trials. Corresponding HRs for all-cause mortality were 1.21(1.11-1.31) and 1.67(1.54-1.81).Conclusions: 44% of individuals with COPD in the general population are excluded from major clinical trials; however, these individuals have increased risk of exacerbations and early death compared to symptomatic smokers without COPD.FootnotesCite this article as Eur Respir J 2022; 60: Suppl. 66, 2376.This article was presented at the 2022 ERS International Congress, in session “-”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -