Introduction

The fixed-dose combination of aclidinium bromide and formoterol (trade names: Duaklir Genuair and Brimica Genuair) has been approved since November 2014 for the treatment of chronic obstructive pulmonary disease (COPD) in adults. Both drugs widen the airways in different ways.

COPD causes permanent damage to the lungs and narrows the airways (bronchi), making it difficult to breathe. Typical symptoms include coughing, phlegm and wheezing, as well as breathing difficulties during physical activity.

Drugs that widen the airways can relieve these symptoms. These medications are called “bronchodilators.” There are long-acting bronchodilators for long-term use and short-acting bronchodilators to relieve acute breathing problems. Aclidinium bromide and formoterol are long-acting bronchodilators. These drugs have been approved for the long-term treatment of COPD in adults.

Application

This drug combination is available as a powder containing 340 micrograms of aclidinium and 12 micrograms of formoterol. It is taken twice a day using a powder inhaler.

Other treatments

For adults, the standard long-term treatment options depend on the severity of the disease:

  • For moderate COPD (stage 2), treatment with long-acting beta2 agonists (formoterol or salmeterol) and/or the long-acting anticholinergic tiotropium is recommended. These drugs are also options for people with severe or very severe COPD (stage 3 and 4).
  • If people have severe or very severe COPD with more than one exacerbation a year, inhaled steroids are an additional option.

Assessment

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the drug combination aclidinium bromide and formoterol for people with COPD when compared with standard therapies.

The manufacturer did not provide any suitable data regarding people with very severe COPD. The question of whether the fixed combination aclidinium bromide / formoterol provides any added benefit in comparison with standard therapies cannot be answered for these people.

The researchers included three studies with a total of about 1,100 participants in their analysis for:

  • People with moderate COPD (stage 2)
  • People with severe COPD (stage 3) who have fewer than two flare-ups per year

The three studies also included data on 56 participants with:

  • severe COPD (stage 3) who have more than one flare-up per year

Learn more

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of the review and hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination aclidinium bromide / formoteril (Duaklir Genuair, Brimica Genuair).

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