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Direct switching to a dual bronchodilator offers benefits in COPD

Elvira Manzano
05 Dec 2017
Dr Dina Diaz

Switching from salmeterol/fluticasone (SFC) to indacaterol/glycopyrronium (IND/GLY) improved lung function in patients with symptomatic, moderate-to-severe, chronic obstructive pulmonary disease (COPD), with a tolerability profile similar to SFC, the multicentre, double-blind, double-dummy, parallel-group phase IV FLASH study has shown.

“The findings reinforce the latest GOLD recommendations which support the use of dual bronchodilation therapy for the majority of symptomatic COPD patients and to limit the use of steroid-containing therapies to specific patient types,” said study investigator Dr Dina Diaz from the Lung Center of the Philippines, Manila, Philippines, who presented the results at APSR 2017 in behalf of principal investigator Professor Peter Frith from the Repatriation General Hospital, Daw Park, Australia. The findings are even more significant as patients were switched to IND/GLY without a washout period, which mimics normal clinical practice.

At week 12, patients switched to IND/GLY had significantly higher mean trough forced expiratory volume in 1 second (FEV1, treatment difference 45 mL; p=0.028). Forced vital capacity (FVC) also significantly improved with IND/GLY (p=0.002). Patients switched to IND/GLY also had numerical improvements in transition dyspnoea index (TDI, 0.46; p=0.063). The proportion of patients with clinically important improvement in TDI (≥1 point; odds ratio [OR],1.27; confidence interval [CI], 0.81–1.97) were also higher in those switched to the dual bronchodilator therapy. [APSR 2017, abstract AOL011]

Previous head-to-head studies have shown the superiority of IND/GLY vs SFC in reducing pulmonary exacerbations in patients with moderate-to-severe COPD. [N Engl J Med 2016;374:2222-2234;  Int J Chron Obstruct Pulmon Dis 2017;12:339-349] FLASH is the first randomized controlled study to demonstrate the benefits of directly switching from SFC to IND/GLY.

The study included 502 patients with moderate-to-severe COPD and daily symptoms, but infrequent exacerbations (<2 within 1 year), who were receiving SFC 50/500μg twice daily for >3 months. They were randomized in a 1:1 ratio to continue SFC or switch, without a washout, to IND/GLY 110/50μg once daily. The primary endpoint was pre-dose FEV1 at week12.

After 12 weeks of treatment, rescue medication use (-0.04 puffs/day; 95 percent CI, 0.20–0.13; p=0.662) and CAT scores (-0.4; 95 percent CI, -1.3–0.4; p=0.319) were comparable between IND/GLY and SFC. Both treatments were well tolerated with similar safety profile. Of note, the proportion of patients with exacerbations was lower with IND/GLY vs SFC (10.1 percent vs 13.2 percent) during the treatment period.

IND is a long-acting beta agonist (LABA) which relaxes and opens air passages in the lungs. Together with the antimuscarinic GLY, it works to ease breathlessness in patients with COPD such as chronic bronchitis and emphysema. The combined therapy is approved in 90 countries as a maintenance bronchodilator treatment to relieve COPD symptoms in adults.

What the current study adds to the current evidence is that directly switching from SFC to IND/GLY, which happens in everyday practice, also have some benefits.

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Roshini Claire Anthony, 13 Aug 2018

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