Swiss drugmaker Novartis has presented positive results from two pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
According to the company, the Expedition, including Flight I, II and III studies and Gem programmes reached their primary and secondary endpoints.
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Expedition data showed that QVA149 when administered twice-daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, met the primary objective.
Novartis Pharmaceuticals development global head Vasant Narasimhan said: "These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life."
In the Gem I and II, NVA237 when administered twice-daily showed better improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo.
The Expedition programme, including Flight I and II, are 12-week multicentre, randomised, double-blind, parallel-group, placebo and active-controlled studies designed to evaluate the efficacy, safety and tolerability of QVA149 in moderate-to-severe COPD patients.
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By GlobalDataFlight III was a 52-week randomised, double-blind and parallel-group study designed to assess the safety and tolerability of QVA149 27.5/12.5 mcg, administered twice-daily, compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.
Gem I and II were 12-week multi-centre, randomised, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of NVA237 12.5mcg, administered twice-daily, in moderate-to-severe COPD patients.
Outside of the US, QVA149 is marketed as Ultibro Breezhaler 110/50mcg and NVA237 is marketed as Seebri Breezhaler 50mcg.
Image: Chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman, MD.
