6/30/23, 12:47 AM WISDOM Pathway Feedback Search Clinical Topics Home Studies WISDOM WISDOM Disease Chronic obstructive pulmonary Trial question What is the effect of withdrawal of ICSs in patients with a history of exacerbations of severe COPD? Study design Multi-center Double blinded RCT Population Characteristics of study participants 18.0% female N = 2485 82.0% male 2485 patients (436 female, 2049 male) Inclusion criteria: patients with a history of exacerbation of COPD receiving triple therapy consisting of tiotropium (at a dose of 18 g once daily), salmeterol (50 g BID), and the ICS fluticasone propionate (500 g BID) during a 6-week run-in period Key exclusion criteria: current clinical diagnosis of asthma; history of thoracotomy with pulmonary resection; unstable or life-threatening cardiac arrhythmia; clinical diagnosis of bronchiectasis; a respiratory tract infection or COPD exacerbation occurring within 6 weeks prior to the initial screening; history of myocardial infarction within 3 months prior to initial screening; or hospitalization for cardiac failure within the past year Interventions N=1242 corticosteroid withdrawal (tiotropium 18 g once daily, salmeterol 50 g BID, and withdrawal of fluticasone in three steps over a 12-week period for 52-weeks) https://web.pathway.md/studies/recoDgQFZyM5NyUxL 1/2 6/30/23, 12:47 AM WISDOM Pathway N=1243 corticosteroid continuation (tiotropium 18 g once daily, salmeterol 50 g BID, and fluticasone 500 g BID for 52-weeks) Primary outcome Moderate or severe chronic obstructive pulmonary disease exacerbation 1.5 % 1.5 1.1 % 1.1 0.8 % Difference not exceeding nonferiority margin 0.4 % 0.0 % Corticosteroid withdrawal Corticosteroid continuation Difference not exceeding nonferiority margin in moderate or severe COPD exacerbation (1.5% vs. 1.1%; HR 1.06, 95% CI 0.94 to 1.19) Safety outcomes No significant difference in adverse events and serious adverse events. Conclusion In patients with a history of exacerbation of COPD receiving triple therapy consisting of tiotropium (at a dose of 18 g once daily), salmeterol (50 g BID), and the ICS fluticasone propionate (500 g BID) during a 6-week run-in period, corticosteroid withdrawal was noninferior to corticosteroid continuation with respect to moderate or severe COPD exacerbation. Reference Magnussen H, Disse B, Rodriguez-Roisin R et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. Open reference URL https://web.pathway.md/studies/recoDgQFZyM5NyUxL 2/2