We are happy to announce that a few days ago the positive results of AstraZeneca’s Bevespi (LABA/LAMA), compared to placebo have been published in the International Journal of COPD. The study shows how FRI confirmed the strong, homogeneous effect of the innovative co-suspension bronchodilator compared to placebo, as seen in earlier studies. At the same time, the results indicate the strong relationship between the FRI endpoints (changes in airway resistance) and clinical endpoints (changes in FEV1), highlighting the clinical relevance of the FRI endpoints once again.
|GFF MDI (n=20)||Placebo MDI (n=19)||LSM ratio of GFF MDI vs placebo MDI||P-value||No of patients/no of lobes||19/92||19/92||19/92||19/92||Geometric LSM||0.09||0.30||0.29||<0.0001||(95% CI)||(0.07-0.11)||(0.23-0.40)||(0.25-0.33)|
Abbreviations: GFF, glycopyrrolate/formoterol fumarate; LSM, least squares mean; MDI, metered dose inhaler; siRaw, specific image-based airway resistance; TLC, total lung capacity.
Figure 1: Functional respiratory imaging co-primary endpoint: siRaw at TLC on Day 15 (kPa⋅s; intent-to-treat population).
This study forms the basis to investigate the effect and added value of LABA, LAMA and ICS, either separately or in combination. The enhanced sensitivity of the FRI parameters (>70% signal versus <30% signal in FEV1) allows for smaller, shorter and less expensive trials.
Click here to read the full study, and contact us now if you wish to receive more information around FRI in clinical trials for therapy analysis.