New LABA inhaler for COPD

Novartis has launched Onbrez Breezhaler (indacaterol), a dry-powder inhaler containing a novel long-acting beta agonist for COPD.

PHARMACOLOGY

Indacaterol is a long-acting partial β2-adrenoceptor agonist with a rapid onset of action. It stimulates intracellular adenyl cyclase, resulting in increased levels of cyclic adenosine monophosphate. This causes relaxation of bronchial smooth muscle; therefore, indacaterol acts locally as a bronchodilator when inhaled.1

CLINICAL STUDIES

The safety and efficacy of indacaterol 150 microgram once daily was assessed in a 12-week, double-blind study in 416 patients with moderate to severe COPD. Patients were randomised to receive either indacaterol or placebo once daily.

Indacaterol had a bronchodilator efficacy superior to that of placebo, as indicated by higher 24-hour post-dose FEV1 values at week 12 (p<0.001) and after the first dose (p<0.001).

The overall rate of adverse events was comparable between the two groups. The most common adverse events were worsening of COPD (incidence of 8.5% in the indacaterol group and 12.2% in the placebo group), and cough (6.2% and 7.3%, respectively).2

In another double-blind study, 1,732 patients with moderate to severe COPD were randomised to receive indacaterol 300 or 600 microgram once daily, formoterol 12 microgram twice daily, or placebo. Investigators measured the trough FEV1 at week 12 and assessed health-related quality of life (HRQOL) using the St George’s Respiratory Questionnaire (SGRQ) at baseline and weeks 4, 8, 12, 24, 44 and 52.

Trough FEV1 (adjusted for baseline lung function, smoking status and country) at week 12 was 1.48L for indacaterol, 1.38L for formoterol and 1.31L for placebo (p<0.001 for both agents vs placebo). Differences in trough FEV1 for both doses of indacaterol against placebo exceeded those for formoterol versus placebo after 1 day (140ml and 170ml vs 110ml), at week 12 (170ml and 170ml vs 70ml) and at week 52 (160ml and 150ml vs 50ml).3

Compared with patients who received placebo, the SGRQ total score was significantly lower at each assessment in those who received indacaterol (p<0.001 for both doses) or formoterol (p<0.01). Differences versus placebo in adjusted mean total score were similar to or exceeded the minimum clinically important difference from week 8 with indacaterol and from week 52 with formoterol.4 The overall incidence of adverse events over ?52 weeks was similar for the active treatments ?and placebo.5

A 26-week randomised, double-blind study compared the effects of indacaterol (150 microgram or 300 microgram once daily), tiotropium (18 microgram once daily; open-label) and placebo in 1,683 patients with moderate to severe COPD. FEV1 was measured at week 12 and HRQOL was evaluated using the SGRQ at baseline and weeks 4, 8, 12 and 26. At week 12, the increases in trough FEV1 compared to placebo were 180ml for both doses of indacaterol and 140ml for tiotropium (p<0.001 for all comparisons vs placebo).

Indacaterol gave better SGRQ total scores than placebo at each assessment (150 microgram, p≤0.001; 300 microgram, p<0.01).

The differences between tiotropium and placebo were not significant. Adverse events occurred at similar rates in the 4 groups.6

View Onbrez Breezhaler drug record

REFERENCES

  1. Onbrez Breezhaler Summary of Product Characteristics, January 2010.
  2. Feldman G et al. BMC Pulm Med 2010; 10: 11.
  3. Dahl R et al. Abstract presented at 19th Congress of European Respiratory Society, Vienna, Austria, September 2009; E4350.
  4. Magnussen H et al. Abstract presented at 19th Congress of European Respiratory Society, Vienna, Austria, September 2009; P2019.
  5. Chung F et al. Abstract presented at 19th Congress of European Respiratory Society, Vienna, Austria, September 2009; E4359.
  6. Donohue J et al. Am J Respir Crit Care Med 2010; doi:10.1164/rccm.200910-1500OC.

Further information: Novartis

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