Novartis recently announced positive first data from its Phase III, head-to-head FLAME clinical trial investigating the rate of chronic exacerbations in patients with obstructive pulmonary disease (COPD) after being treated with its investigational COPD therapy.
The data showed that a dose of 110/50 mcg of Ultibro Breezhaler (indacaterol/glycopyrronium) once per day met its primary non-inferiority outcome and also demonstrated clinical superiority to 50/500 mcg of Seretide (salmeterol/fluticasone) twice per day in decreasing the rate of mild/moderate/severe COPD exacerbations over a course of one year of treatment.
The data is in line with the previous LANTERN clinical trial, which has now been extended to patients who have had at least one COPD exacerbation in the previous year. In line to the initial FLAME trial results, the safety profiles of the two regimens were consistent with their known profiles.
“Today’s FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals in a recent press release. “We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients.”
In an upcoming scientific forum, Novartis will report the The full FLAME trial data, including results from further secondary outcomes.
FLAME was a double-blind, randomized, parallel-group, non-inferiority, active-controlled trial for a period of 52 weeks. A total of 3,362 COPD patients were involved in the trial, which was conducted at 356 sites across 43 countries.
The trial is the final one of eleven trials in the IGNITE Phase III clinical trial program investigating Ultibro Breezhaler as a COPD treatment.
The trial primary outcome was the assessment of 110/50 mcg of Ultibro Breezhaler non-inferiority to 50/500 mcg of salmeterol/fluticasone (SFC) in terms of rate of mild/moderate/severe COPD exacerbations during 52 weeks of treatment.
The trial secondary outcomes included superiority in terms of rate of all COPD exacerbations over the duration of the trial and clinical efficacy including: time to first mild/moderate/severe COPD exacerbation; time and rate to first moderate-to-severe COPD exacerbation; lung function (assessed by FEV1); health-related quality of life (assessed by the SGRQ-C questionnaire); the use of rescue medication and safety.
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