@article{Chapman:2018:10.1164/rccm.201803-0405OC,
author = {Chapman, KR and Hurst, JR and Frent, S and Larbig, M and Fogel, R and Guerin, T and Banerji, D and Patalano, F and Goyal, P and Pfister, P and Kostikas, K and Wedzicha, JA},
doi = {10.1164/rccm.201803-0405OC},
journal = {American Journal of Respiratory and Critical Care Medicine},
pages = {329--339},
title = {Long-term triple therapy de-escalation to indacaterol/glycopyrronium in COPD patients (SUNSET): a randomized, double-blind, triple-dummy clinical trial},
url = {http://dx.doi.org/10.1164/rccm.201803-0405OC},
volume = {198},
year = {2018}
}

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TY  - JOUR
AB  - Rationale: There are no studies on ICS withdrawal in patients on long-term triple therapy in the absence of frequent exacerbations. Objective: To evaluate the efficacy and safety of the direct de-escalation from long-term triple therapy to indacaterol/glycopyrronium in non-frequently exacerbating COPD patients. Methods: This 26-week, randomized, double-blind, triple-dummy study assessed the direct change from long-term triple therapy to indacaterol/glycopyrronium (110/50μg once daily) or continuation of triple therapy (tiotropium 18μg once daily plus combination of salmeterol/fluticasone propionate [50/500μg] twice daily) in non-frequently exacerbating patients with moderate-to-severe COPD. Primary endpoint was non-inferiority on change from baseline in trough forced expiratory volume in 1 second (FEV1). Moderate or severe exacerbations were predefined secondary endpoints. Measurements and Main Results: 527 patients were randomized to indacaterol/glycopyrronium and 526 to triple therapy. ICS withdrawal led to a reduction in trough FEV1 of −26mL (95% confidence interval [CI], −53 to 1 mL) with confidence limits exceeding the non-inferiority margin of −50 mL. The annualized rate of moderate or severe COPD exacerbations did not differ between treatments (rate ratio 1.08; 95%CI, 0.83 to 1.40). Patients with ≥300 blood eosinophils/μL at baseline presented greater lung function loss and higher exacerbation risk. Adverse events were similar in the two groups. Conclusions: In COPD patients without frequent exacerbations on long-term triple therapy, the direct de-escalation to indacaterol/glycopyrronium led to a small decrease in lung function, with no difference in exacerbations. The higher exacerbation risk in patients with ≥300 blood eosinophils/µL suggests that these patients are likely to benefit from triple therapy. Clinical trial registration available at www.clinicaltrials.gov, ID NCT02603393.
AU  - Chapman,KR
AU  - Hurst,JR
AU  - Frent,S
AU  - Larbig,M
AU  - Fogel,R
AU  - Guerin,T
AU  - Banerji,D
AU  - Patalano,F
AU  - Goyal,P
AU  - Pfister,P
AU  - Kostikas,K
AU  - Wedzicha,JA
DO  - 10.1164/rccm.201803-0405OC
EP  - 339
PY  - 2018///
SN  - 1073-449X
SP  - 329
TI  - Long-term triple therapy de-escalation to indacaterol/glycopyrronium in COPD patients (SUNSET): a randomized, double-blind, triple-dummy clinical trial
T2  - American Journal of Respiratory and Critical Care Medicine
UR  - http://dx.doi.org/10.1164/rccm.201803-0405OC
UR  - https://www.atsjournals.org/doi/10.1164/rccm.201803-0405OC
UR  - http://hdl.handle.net/10044/1/60250
VL  - 198
ER  - 

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