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Stable COPD Patients May Not Need Added Inhaled Corticosteroid to Prevent Exacerbations


Embargoed Until
May 20, 11:15 a.m. (PT)



Dacia Morris

Cell Phone: 917-561-6545


Session: A75 COPD: Targets, Models, and Clinical Studies

Abstract Presentation Time: Sunday, May 20, 11:15 a.m. (PT)

Location: Room Area E (Hall A-B2, Ground Level) - San Diego Convention Center


Stable COPD Patients May Not Need Added Inhaled Corticosteroid to Prevent Exacerbations

ATS 2018, San Diego, CA –COPD patients who do not exacerbate frequently but who are using a complex regimen including inhaled corticosteroids (ICS) may not need the ICS component if they de-escalate to a simplified contemporary regimen that combines a long-acting muscarinic antagonist and a long-acting beta-agonist in a single inhaler. 

These were the findings of a randomized controlled trial presented at the ATS 2018 International Conference and published online in the American Journal of Respiratory and Critical Care Medicine.

In “Long-term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in COPD Patients (SUNSET): a Randomized, Double-Blind, Triple-Dummy Clinical Trial,” lead study author Kenneth Chapman, MD, MSc, and coauthors described the first randomized controlled study investigating ICS withdrawal in stable COPD patients on long-term triple therapy.

Current COPD guidelines recommend that ICS be used only for the minority of COPD patients who exacerbate frequently but many stable, non-exacerbating patients end up on complex triple regimens that include ICS.  The SUNSET study enrolled 1,053 such patients without frequent COPD exacerbations and randomly selected 527 of them to take the new long-acting muscarinic antagonist and a long-acting beta-agonist, indacaterol/glycopyrronium (110/50 once daily), without an ICS. The remainder continued on the triple regimen. 

Those taking only indacaterol/glycopyrronium were no more likely to have an exacerbation than those who remained on their triple therapy during the six-month study. Nor was there a difference in the time to the first exacerbation or the use of rescue inhalers between the two groups of patients.

Because inhaled corticosteroid use is associated with increased risk of pneumonia, mycobacterial infections, diabetes and factures, the authors believe that this study finding may have important implications for clinical care.

“As fundamental as inhaled corticosteroids are to the management of persistent asthma, they are of benefit to only a minority of patients with COPD,” said Dr. Chapman, professor of medicine at the University of Toronto.  “The SUNSET trial will help to return focus to the bronchodilator foundation of COPD pharmacotherapy and will encourage physicians to personalize the care of COPD, reserving inhaled corticosteroids for the minority of patients who might benefit.

The study did note that those receiving indacaterol/glycopyrronium without an ICS experienced a small, but statistically significant, decline in lung function. FEV1, or the amount of air that can be forcefully exhaled in one second, was 26 milliliters less in those receiving indacaterol/glycopyrronium than in those continuing triple therapy a day after the medications were taken.  

“The change is of doubtful clinical significance and is too small to be measured reliably in individual patients,” the authors said.

Although the overall patient group showed no adverse effects of ICS withdrawal, a close look at the results suggested that a minority of patients with persistently elevated blood eosinophil counts (above ≥300 cells/microliter) may have done better continuing with their previously prescribed ICS. Eosinophils are immune cells associated with COPD exacerbations, and in this study, those with high counts appeared to be at greater risk of exacerbations after the ICS was withdrawn. If borne out by further studies, this would offer a convenient marker to help guide prescribing, the authors said.

Ex-smokers also appeared to benefit from taking an ICS through improved lung function, though the authors noted that the group size was too small to reach a definitive conclusion.

“Several studies of COPD populations suggest that only about 20 percentage exacerbation-prone and might therefore benefit from inhaled corticosteroid use as part of their treatment, Dr. Chapman said. “Given emerging concerns about inhaled corticosteroid side effects, the SUNSET trial should encourage physicians to focus on the dual bronchodilator foundation of COPD pharmacotherapy for the majority of their patients and reserve ‘triple therapy’ for the minority who suffer frequent exacerbations, particularly if the blood eosinophil count is persistently elevated.”

The study was funded by Novartis Pharma AG, which manufactures the indacaterol/glycopyrronium bronchodilator under the brand name Ultibro® Breezhaler®.

Contact for Media

Kenneth Chapman, MD, MSc