First 3-in-1 inhaler for asthma launched

Enerzair Breezhaler combines the long-acting ß₂ agonist (LABA) indacaterol, the inhaled corticosteroid (ICS) mometasone furoate and the long-acting muscarinic antagonist (LAMA) glycopyrronium.

It is licensed for the maintenance treatment of asthma in adults who are not adequately treated by the combination of a LABA and a high-dose of an ICS, and who have had 1 or more asthma exacerbations in the previous year.  

The once-daily inhaler is available in one strength and each delivered dose of the inhaler (the dose leaving the mouthpiece) contains 114 micrograms of indacaterol (as acetate), 46 micrograms of mometasone furoate and 58 micrograms of glycopyrronium (as bromide).

Enerzair Breezhaler can be prescribed together with a digital companion: a sensor and an app that provides inhalation confirmation, medication reminders and access to objective data to support therapeutic decisions. 

'Once-daily Enerzair Breezhaler plus a digital companion could help to facilitate greater collaborative disease management between physicians and patients in the EU whose asthma remains uncontrolled, despite LABA/ICS treatment,' said Professor David Price, Chair of Primary Care Respiratory Medicine at the University of Aberdeen. 

The manufacturer of Enerzair Breezhaler, Novartis, has also launched Atectura Breezhaler, a combination of the LABA indacaterol and the ICS mometasone furoate. It is licensed as a maintenance treatment for asthma in adults and adolescents >12 years who are not adequately controlled with a short-acting beta₂-agonist and an ICS.

Atectura Breezhaler is available in three strength: 125/62.5 microgram, 125/127.5 microgram and 125/260 microgram, and is used once daily. 

Dry-powder inhalers

The two new inhalers use the breath-actuated, dry powder Breezhaler device, which is also available as Onbrez Breezhaler, Seebri Breezhaler and Ultibro Breezhaler. 

There are three steps to using the Breezhaler inhaler: open and insert a capsule, close and pierce the capsule, inhale. The capsule component of both Enerzair Breezhaler and Atectura Breezhaler is transparent, allowing the patient to see that they have taken the full dose of their medication. 

Clinical trials

IRIDIUM was a randomised, double-blind, 52-week phase III study comparing the efficacy of once-daily indacaterol/mometasone/glycopyrronium (IND-MF-GLY) 114/68/46 microgram (n=620) with indacaterol/mometasone (IND-MF) 125/127.5 microgram (n=617), and IND-MF-GLY 114/136/46 microgram (n=619) with IND-MF 125/260 microgram (n=618). All participants had symptomatic asthma and had been taking an ICS and a LABA for at least three months. 

The primary endpoint was the change from baseline in trough FEV₁ with IND-MF-GLY versus IND-MF at week 26. At week 26, patients treated with IND-MF-GLY 114/136/46 microgram showed a significant improvement in trough FEV₁ versus those who received IND-MF 125/260 microgram (treatment difference of 0.065L [CI 0.033-0.099], p<0.001). A similar outcome was seen when comparing IND-MF-GLY 114/68/46 microgram and IND-MF 125/127.5 microgram. 

Similarly, in the PALLADIUM trial, which compared IND-MF to MF alone, a significant improvement in trough FEV₁ was observed in the IND-MF 125/260 microgram group compared to the MF 800 microgram group (treatment difference of 0.132L [CI 0.088-0.176], p<0.001). 

Adverse effects

The most commonly reported adverse effects of both inhalers were nasopharyngitis, upper respiratory tract infection and headache.