Duaklir Genuair: new formoterol/aclidinium inhaler for COPD

15 December 2014

Duaklir Genuair (formoterol fumarate dihydrate/aclidinium bromide) has been launched for use as a maintenance treatment in adults with chronic obstructive pulmonary disease (COPD).

The recommended dose of Duaklir Genuair is one inhalation twice daily.

PHARMACOLOGY

Formoterol is a long-acting beta₂ agonist (LABA) and aclidinium is a long-acting muscarinic receptor antagonist (LAMA).¹

CLINICAL STUDIES

The clinical efficacy of the fixed-dose formoterol/aclidinium combination was evaluated in two 24-week, double-blind, phase III studies (AUGMENT COPD and ACLIFORM COPD) involving approximately 4,000 patients with COPD. Patients were randomised to receive twice-daily inhaled formoterol plus aclidinium, formoterol or aclidinium monotherapy or placebo.^1-3

Lung function

In the AUGMENT COPD study (n=1692), a significantly greater improvement in lung function (as defined by improvement from baseline in 1-hour post-dose FEV₁) was observed at week 24 for the formoterol/aclidinium fixed-dose combination compared with aclidinium monotherapy (+108ml; p<0.0001).²

Improvement in trough FEV₁ was also significantly greater in patients treated with formoterol/aclidinium versus formoterol monotherapy (+45ml; p=0.0102).²

Dual therapy with formoterol/aclidinium also produced a significant improvement from baseline in 1-hour post-dose FEV₁ compared to aclidinium monotherapy in the ACLIFORM study (+125ml; p<0.001). Formoterol/aclidinium significantly improved trough FEV₁ over formoterol monotherapy, with a least squares mean difference of +85ml (p<0.001).³

Significant and rapid improvements in bronchodilation observed on day 1 were maintained throughout both 24-week studies.^1–3

Breathlessness

At week 24 in the ACLIFORM study, a significant improvement in transient dyspnoea index (TDI) focal score was observed with the formoterol/aclidinium fixed-dose combination compared with placebo (1.29 units, 95% CI 0.73–1.86; p<0.001).³

Night-time and early morning symptoms

Overall early morning and night-time symptom severity (including cough, wheezing, breathlessness and difficulty bringing up phlegm) was significantly improved with the formoterol/aclidinium fixed-dose combination compared with placebo and either monotherapy (p<0.05 for all comparisons), except at week 4 for the combination versus formoterol monotherapy in the AUGMENT study.^2,3

Rescue medication

The use of rescue medication over 6 months was significantly reduced by -0.91 puffs per day with formoterol/aclidinium compared with placebo (p<0.001).¹

Quality of life

In both studies, more than 50% of patients administered formoterol/aclidinium achieved the minimum clinically important difference (4 units) in St George's Respiratory Questionnaire total score at week 24.¹

Exacerbations

In a pooled analysis of both studies, aclidinium/formoterol reduced moderate to severe exacerbations assessed by healthcare resource utilisation (HCRU) by 29% versus placebo (p<0.05) and 22% when assessed by the exacerbations of chronic pulmonary disease tool (EXACT) (p<0.01).⁴

Safety

Patients treated with the fixed-dose combination of aclidinium and formoterol experienced similar adverse reactions to those receiving the individual components, most commonly nasopharyngitis and headache.¹