New triple combination dry powder inhaler launched for COPD

Trimbow NEXThaler is a breath-actuated dry powder inhaler containing beclometasone, formoterol and glycopyrronium licensed for use in adults with moderate to severe COPD.

The recommended dose for Trimbow NEXThaler is two inhalations twice daily. | Chiesi Limited
The recommended dose for Trimbow NEXThaler is two inhalations twice daily. | Chiesi Limited

Trimbow NEXThaler is a breath-actuated dry powder inhaler (DPI) containing beclometasone, formoterol and glycopyrronium (delivered dose: 88 microgram, 5 microgram and 9 microgram, respectively).

Trimbow NEXThaler is licensed for maintenance treatment in adults with moderate to severe COPD where an inhaled corticosteroid plus a long-acting ß2 agonist, or a long-acting anticholinergic plus a long-acting ß2 agonist, is inadequate.

The triple combination is already available as a pressurised metered dose inhaler (pMDI), Trimbow pMDI 87/5/9, licensed for the maintenance treatment of both asthma and COPD.

Extrafine formulation

Prescribers should note that the active ingredients in both Trimbow products are delivered as extrafine particles to improve lung deposition, meaning that the beclometasone doses are not equivalent to those delivered by non-extrafine formulations. Owing to the difference in particle sizes, 250 microgram beclometasone administered via a standard inhaler is therapeutically equivalent to 100 microgram beclometasone in a Trimbow product when given via the NEXThaler device or the pMDI.

Non-inferiority study

Non-inferiority of beclometasone/formoterol/glycopyrronium delivered via DPI compared with delivery via pMDI was assessed in a phase II double-blind, double-dummy, active-controlled, threeway crossover study (n=342). Adults with COPD and FEV1 30-80% predicted entered a two-week washout period where they received beclometasone/formoterol via pMDI (100/6 microgram, 2 puffs twice daily) before being randomised to one of six treatment pathways.

Each pathway comprised three four-week treatment blocks where participants received the triple combination via DPI, the triple combination via pMDI or beclometasone/formoterol via pMDI, each separated by a two-week washout period with beclometasone/formoterol via pMDI. Patients were assessed on days 1 and 28 of each treatment block.

Study findings

The two co-primary objectives for the study (changes from baseline in FEV1 area under the curve between 0 and 12 hours post-dose [AUC0-12h] and trough FEV1 at 24 hours, both on day 28) were similar for the two triple combination formulations, with confidence intervals for the difference lying entirely within the pre-specified non-inferiority criterion. Both formulations were statistically superior to the dual combination for these endpoints (p<0.001).

A similar proportion of patients experienced adverse effects with each treatment, which were, for the most part, mild or moderate.

The study authors conclude that the extrafine beclometasone/formoterol/glycopyrronium DPI and pMDI demonstrated similar efficacy and safety in patients with COPD, supporting the DPI as a valid alternative.

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