Chapman, KR;
Hurst, JR;
Frent, S-M;
Larbig, M;
Fogel, R;
Guerin, T;
Banerji, D;
... Wedzicha, JA; + view all
(2018)
Long-term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in COPD Patients (SUNSET): a Randomized, Double-Blind, Triple-Dummy Clinical Trial.
American Journal of Respiratory and Critical Care Medicine
, 198
(3)
pp. 329-339.
10.1164/rccm.201803-0405OC.
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Abstract
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.
| Type: | Article |
|---|---|
| Title: | Long-term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in COPD Patients (SUNSET): a Randomized, Double-Blind, Triple-Dummy Clinical Trial |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1164/rccm.201803-0405OC |
| Publisher version: | http://dx.doi.org/10.1164/rccm.201803-0405OC |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | COPD, Indacaterol/glycopyrronium, exacerbation, lung function, triple therapy |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Respiratory Medicine |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10049977 |
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