DUAKLIR GENUAIR

Reevaluation.

Favourable opinion for reimbursement as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The clinical benefit is now moderate, where previously it was insufficient.

What therapeutic improvement?

No clinical added value compared to the other free or fixed long-acting β2-adrenergic agonist (LABA) and long-acting muscarinic antagonist (LAMA) combinations, indicated in adult patients with COPD.

Role in the care pathway?

The diagnosis and management of patients with COPD must include an assessment of the COPD severity stage based on symptoms (chronic cough, dyspnoea on exertion, purulent expectoration, exacerbations) and lung function status.

Quitting smoking is the only measure liable to slow the decline in FEV₁. Influenza vaccination is recommended. To date, no medicinal products have demonstrated an effect on prevention of progression of COPD towards chronic respiratory insufficiency. Cardiorespiratory rehabilitation for exercise leads to an improvement in symptoms, quality of life and participation in activities of daily living, and helps reduce the incidence of exacerbations. The choice of medicinal treatments depends on the symptoms (dyspnoea, exacerbations).

The medicinal management of COPD, outside of exacerbations, is conducted in steps, depending on the severity stage and the response to treatment. The medicinal products used are aimed at:

• Preventing and controlling symptoms;
• Reducing the frequency and severity of exacerbations;
• Improving quality of life;
• Improving exercise tolerance.

Long-acting β2-adrenergic agonist (LABA) and long-acting muscarinic antagonist (LAMA) bronchodilators are recommended when maintenance symptomatic treatment is required, i.e., when daily incapacitating symptoms persist despite the repeated daily use of a short-acting bronchodilator.

A clinical and functional reassessment is offered 1 to 3 months after the prescription of any new medicinal product, then every 3 to 12 months, depending on the severity of the COPD.

If dyspnoea persists, the combination of a long-acting β2-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA) may improve lung function (FEV₁), quality of life and dyspnoea and may reduce exacerbations without increasing adverse effects.

In the event of frequent exacerbations despite optimal bronchodilator treatment, a combination of LABA + inhaled corticosteroids (ICS) may be proposed, complying with the FEV₁ levels of the MA, or, in the event of associated dyspnoea (mMRC ≥ 2), a LABA + LAMA combination. Triple therapy (LABA + LAMA + ICS) is indicated if exacerbations persist despite one of these options. If dyspnoea or exacerbations persist despite triple therapy, other treatments should be envisaged (macrolides if exacerbations, low-dose morphine derivatives if refractory dyspnoea, discussion of endobronchial treatments in a specialised centre).

Continuous oxygen therapy is reserved for patients with daytime hypoxaemia (PaO2 ≤ 55 mmHg) observed outside an acute episode despite optimal treatment.

Role of the medicinal product in the care pathway

DUAKLIR GENUAIR, a fixed combination of aclidinium and formoterol, is a second-line treatment in patients with moderate to very severe COPD following an inadequate response to a long-acting bronchodilator used as monotherapy.