Clinical Trials

Functional Respiratory Imaging (FRI), our breakthrough biomedical imaging technology, significantly enhances the work of pharmaceutical companies and academic research organizations performing early phase clinical trials. It has been used for the evaluation of novel compounds in the respiratory therapeutic area for the treatment of asthma, Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF) and Cystic Fibrosis (CF). FRI also allows efficient selection of the most personalized therapy for patients with sleep disorders.

  • FRI identifies the most promising respiratory drugs in a cost and time-effective way.
  • FRI reduces the number of patients in the clinical trial by a factor 3-8 while preserving statistical significance. [1] [2]
  • FRI helps to identify ineffective therapies sooner (fail fast – fail often).
  • FRI speeds up the registration process of compounds in the therapeutic area of respiratory diseases.
  • The benefits of FLUIDDA’s proprietary FRI technology have been validated in over 25 clinical trials involving a total of 10.000 scans performed in collaboration with various academic and medical research centers.
  • The trials confirmed the higher sensitivity of our novel FRI approach over that of existing standard diagnostic tests such as spirometry.

Application of FRI

The use of FRI in clinical trials can have a major positive impact on cost and patient treatment. FLUIDDA’s technology can decrease the cost and development time in the pre-clinical and clinical phases and facilitate the transition between the two phases:

  • In the pre-clinical phase, there is no need for patient involvement when using FRI. Costs are decreased by speeding up the process through the use of realistic animal and patient-specific models. These models are used to assess aerosol deposition patterns as a function of the different parameters (inhaler, inhalation profile, etc.) without patient involvement.
  • In the clinical phase cost reduction is achieved by using more sensitive measurements, such as segmented airway volume changes or changes in CFD-based resistance, which provide more information. This makes it possible to optimize the design of the costly phase III study and identify ineffective therapies early.
  • Using a common parameter, such as an animal or patient-specific model, results in the optimization of the translational process.  Iterations can be performed on inhaler design or particle formulation, resulting in products with a high chance of improving the conditions of the targeted patient population. Feedback from the clinical trials also makes it possible to update the model for future trials with other new products.