Novartis's Phase IV trial of Onbrez Breezhaler in COPD patients meets primary objective
Novartis has reported positive results from the Phase IV INSTEAD switch trial of Onbrez Breezhaler carried out in patients with chronic obstructive pulmonary disease (COPD).
The company said that the trail met its primary objective and the once-daily Onbrez Breezhaler (indacaterol) 150mcg showed non-inferiority in lung function at week 12 to twice-daily Seretide (salmeterol/fluticasone propionate (SFC)) 50/500mcg in patients with moderate COPD who had experienced no exacerbations in the previous year.
The global, randomised, double-blind, parallel-group, 26-week INSTEAD trial also demonstrated similar symptomatic benefits in terms of shortness of breath and health status after 12 and 26 weeks in patients treated with Onbrez Breezhaler compared to those on SFC.
Safety profile of the drug observed in the Phase IV trial was consistent with previously reported results from Phase III studies.
Novartis Pharmaceuticals global head of development Tim Wright said the positive results help inform the switch from salmeterol/fluticasone to Onbrez Breezhaler in patients with moderate COPD and who are at low-risk of exacerbations.
"This confirms that Onbrez Breezhaler provides an effective maintenance treatment option for these patients," Wright said.
"In addition, these results support international guidelines, which advise against the use of inhaled corticosteroids due to long-term risks in COPD patients at low risk of exacerbations."
A total of 581 patients with moderate COPD have been randomised in the trial who had been taking SFC for at least three months to either continue on SFC or switch to indacaterol.
Onbrez Breezhaler is a once-daily inhaled long-acting beta2-adrenergic agonist (LABA) that provides clinically relevant 24 hour bronchodilation combined with a rapid onset of action within five minutes at first dose, as showed in the INERGIZE Phase III trial programme.
It was first approved and launched in the EU (150mcg and 300mcg once-daily doses) for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD.
Image: A chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman.