Chiesi Farmaceutici released the pre-specified pooled analysis efficacy and safety data from PIII TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) trials . Study authors concluded that by week 26, BDP/FF/G improved pre-dose FEV1 by 57mL (95% CI 15–99; p=0.0080) and 73mL (26–120; p=0.0025) versus BDP/FF in TRIMARAN and TRIGGER, respectively, with 15% (rate ratio 0.846 [0.725–0.987]; p=0.0331) and 12% (0.880 [0.751–1.030]; p=0.1102) reductions in moderate-to-severe exacerbation rate over 52 weeks . BDP/FF/G reduced the rate of severe exacerbations vs. BDP/FF by 23% (p=0.0076), reduced the rate of moderate exacerbations by 12% (p=0.0427), and reduced the rate of combined moderate and severe exacerbations by 14% (p=0.0083) .
PIII studies TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) have completed but results are not currently available .
PIII TRIGGER trial to evaluate the superiority of beclometasone + formoterol + glycopyrrolate (200/6/12.5µg), compared with beclometasone + formoterol (200/6µg) and beclometasone + formoterol (200/6µg) in combination with tiotropium (2.5µg), followed by assessment of its safety and health economic outcomes in patients with asthma starts (NCT02676089). The randomized, double-blind trial is designed to enrol approximately 1,435 patients in Western Europe. Collection of primary outcome data (pre-dose FEV1 and moderate and severe exacerbation rate) is expected to complete Jul 18 [2,3].
PIII study to evaluate safety and efficacy of beclometasone + formoterol + glycopyrrolate (100/6/12.5 µg), with beclometasone + formoterol (100/6/µg), in patients with asthma that is uncontrolled on medium strength regimen of inhaled corticosteroids plus long acting β agonist starts (TRIMARAN; NCT02676076). Approximately 1148 subjects, aged 18 to 75 years, will be enrolled in the trial. Enrolment is underway in Western European counties including the UK. Collection of primary outcome data (pre-dose FEV1 and moderate and severe exacerbation rate) is expected to complete Jun 18 [2,3].