Ultibro Breezhaler: LABA/LAMA fixed-dose combination inhaler

Novartis has launched Ultibro Breezhaler, a breath-actuated dry powder inhaler containing indacaterol and glycopyrronium bromide, for the maintenance treatment of COPD.

Patients should inhale the contents of one Ultibro capsule using the Breezhaler device once daily at the same time each day.
Patients should inhale the contents of one Ultibro capsule using the Breezhaler device once daily at the same time each day.

PHARMACOLOGY

Indacaterol is a long-acting beta2 agonist (LABA) and glycopyrronium is a long-acting antimuscarinic antagonist (LAMA). When inhaled, both drugs result in bronchodilation via the relaxation of smooth muscle in the airways. Their effects are additive owing to the different mechanism of action of each drug.1

The two drugs have been available for some time as single-component products for use with the Breezhaler device: indacaterol as Onbrez; and glycopyrronium as Seebri.

CLINICAL STUDIES

The efficacy of the once-daily indacaterol/glycopyrronium combination inhaler was compared with that of the individual components, tiotropium 18 microgram (administered via HandiHaler) and placebo in the pivotal 26-week double-blind phase III study (SHINE) involving 2,144 patients with moderate to severe COPD.2

Trough FEV1 at week 26 (the primary endpoint) was significantly improved in patients using the combination inhaler compared with those receiving indacaterol or glycopyrronium monotherapy (least squares mean difference +70ml and +90ml, respectively), tiotropium (+80ml) and placebo (+200ml); p<0.001 for all comparisons.2

In the ILLUMINATE study, 523 patients with moderate to severe COPD were randomised to receive once-daily indacaterol/glycopyrronium via the Breezhaler or twice-daily salmeterol 50 microgram plus fluticasone 500 microgram via the Accuhaler device over 26 weeks. Both groups also received placebo via whichever inhaler type they were not using for their active treatment.3

Treatment with indacaterol plus glycopyrronium resulted in a greater improvement in FEV1 12 hours post-dose than treatment with salmeterol/fluticasone, with an observed treatment difference of 138ml at week 26 (95% CI 0.1-0.176; p<-0.0001).3

The effect of the combination inhaler on the rate of exacerbations in severe and very severe COPD (n=2,224) was assessed in the 64-week, parallel-group SPARK study. Patients were randomised to receive once-daily indacaterol plus glycopyrronium, glycopyrronium monotherapy or tiotropium 18 microgram.4

Indacaterol/glycopyrronium reduced the rate of moderate to severe exacerbations versus glycopyrronium monotherapy by 12% (p=0.038). The reduction in rate of moderate to severe exacerbations for indacaterol/glycopyrronium versus tiotropium was 10% but this was not statistically significant.4

Safety profile

In clinical studies, patients treated with the combination of indacaterol and glycopyrronium experienced similar adverse reactions to those receiving the individual components, characterised by typical anticholinergic and beta-adrenergic symptoms. Other common adverse reactions included cough and oropharyngeal pain/irritation.1

References

  1. Ultibro Breezhaler Summary of Product Characteristics, January 2014.
  2. Bateman ED et al. Eur Respir J 2013; 42: 1484–94.
  3. Vogelmeier CF et al. Lancet Respir Med 2013; 1: 51–60.
  4. Wedzicha JA et al. Lancet Respir Med 2013; 1: 199–209.

View Ultibro Breezhaler drug record

Further information: Novartis

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