Duaklir Genuair: new formoterol/aclidinium inhaler for COPD

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.
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 0.731.86; 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

References

  1. Duaklir Genuair Summary of Product Characteristics, November 2014.
  2. D'Urzo AD et al. Respir Res 2014; 15: 123.
  3. Singh D et al. BMC Pulm Med 2014; 14: 178.
  4. Batemen ED et al. Poster presented at ERS, Munich, Germany, September 2014.

View Duaklir Genuair drug record

Further information: AstraZeneca

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