Tag Archives: FRI

FRI shows clinically meaningful benefits of Bevespi in COPD

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.

How is FRI a solution to your research question?

How is FRI a solution to your research question?

  We’ve said it before: the respiratory field is the most expensive one in the pharmaceutical world. The low sensitivity of several clinical biomarkers make it difficult for therapy developers to limit the size of their trails. Similarly, in the clinical domain, high costs occur among others from insensitive or difficult measurements, late detection of… Continue Reading

I:E and breathing control in CF drug delivery – what makes or breaks treatment?

  Cystic fibrosis (CF) is a devastating, chronic disease that affects over 100,000 people worldwide. The consequences patients need to bear with them for the rest of their lives are even more devastating. A CF patient is signed for continuous care, daily treatments, hours of daily physiotherapy sessions and regular hospital check-ups or visits, next… Continue Reading

FRI deposition analysis: when a model becomes a measurement

In the previous blogpost the complexity of delivering inhaled drugs into the lung was discussed. It was shown that functional respiratory imaging is able to give an accurate measurement of the amount of drug reaching the lungs of patients with different respiratory diseases. The accuracy of functional respiratory imaging is not the result of some… Continue Reading

SimInhale Symposium at DDL2017

Our COO Wim Vos had a very interesting discussion this morning on drug delivery into the lungs of children and infants. Can FLUIDDA‘s FRI be the tool to evaluate the performance of nebulized , DPI or soft mist delivery in this population? SimInhale #DDL2017 Continue Reading

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Fluidda NV

Groeningenlei 132

2550 Kontich

Belgium

BE 0877 160 706

Tel: +32/(0)3 450 87 20

Fax: +32/(0)3 450 87 29

info@fluidda.com

FLUIDDA, Inc

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United States

FLUIDDA, Inc

675 US Highway One
North Brunswick, NJ 08902
United States

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Medical Imaging pvt ltd
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Nashik 422010
India

FLUIDDA India

Medical Imaging pvt ltd
A-95/96, DGP Nagar -2, Ambad
Nashik 422010
India

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