The addition of glycopyrronium bromide (GB) to inhaler therapy with beclomethasone dipropionate (BDP) formoterol fumarate (FF) improved lung function and exacerbations among patients with uncontrolled asthma receiving medium dose inhaled corticosteroids (ICS)/ long-acting beta agonists (LABA), according to recent research presented at the American Thoracic Society International Conference in Dallas.

“Maintenance treatment with the single-inhaler extrafine BDP/FF/GB triple [pressurized metered dose inhaler (pMDI)] significantly improved lung function and the rate of moderate-severe exacerbations compared to BDP/FF in subjects with uncontrolled asthma despite medium dose ICS/LABA,” Pierluigi Paggiaro, MD, from the Respiratory Pathophysiology and Rehabilitation Department at Cisanello University Hospital in Pisa, Italy, and colleagues wrote in their abstract. “Both treatments were safe and well tolerated.”

Presentation room. Source: Getty

In the phase 3, multi-center, randomized, double-blinded TRIMARAN (TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA) study, Dr. Paggiaro and colleagues enrolled 1,155 patients (61.7% females). All asthma patients were being treated with medium dose ICS and LABA.

Researchers randomized 579 patients to receive BDP/FF/GB and 576 patients to receive BDP/FF over 52 weeks of treatment. The BDP/FF/GB group received two doses of 100/6/12.5 µg twice daily, while the fixed dose combination BDP/FF group received two doses of 100/6 µg twice daily.

The researchers found at 26 weeks, patients in the triple-therapy group had a higher trough FEV1 score (57 mL from baseline) than double-therapy patients (P = .008). There was a 15.4% reduction in moderate and severe exacerbations from the triple-therapy  group (P = .033) compared with patients in the double-therapy group. Secondary endpoints in the study included change in FEV1 Peak0-3h (84 mL from baseline) and peak expiratory flow (PEF) at 26 weeks (8.46 mL from baseline), which was statistically significantly different in favor of triple-therapy patients compared with double-therapy patients (P < .001).

With regard to adverse events, fewer patients receiving triple therapy experience treatment-emergent adverse events (74.8% vs. 79.3%) compared with those in the double-therapy group. However, the number of adverse events was higher in the triple-therapy group (4.9% vs 3.8%). The researchers noted fewer than 1% of patients overall discontinued treatment due to an adverse event.