A study to support lung deposition modelling for inhaler technologies

• Research type

  Research Study

• Full title

  A prospective study to support validation of Computational Fluid Dynamics based lung deposition models with nuclear medicine imaging methods

• IRAS ID

  359142

• Contact name

  Hosein Sadafi

• Contact email

  hosein.sadafi@fluidda.com

• Sponsor organisation

  FLUIDDA

• Duration of Study in the UK

  0 years, 3 months, 21 days

• Research summary

  The purpose of this study is to generate lung deposition data for various populations i.e., healthy volunteers, patients with asthma and patients with COPD to support the building of a computer model/simulation which can be used to assess the effectiveness of different inhaler technologies used in the treatment of various lung conditions such as asthma and COPD.

  The intention of the study is to generate this data such that this computer model may be used in future to allow developers of new inhaler technologies to be able to predict how effective their technology will be in delivering the study drug to the desired areas in the lungs.

  The study will consist of 15 participants: 5 healthy volunteers, 5 patients with asthma and 5 patients with COPD. Each participant will be required to complete three gamma scintigraphy imaging periods which will involve the administration of three different commercially available inhalers. Across the three periods, each participant will receive:

  A single dose of Atrovent®, Flixotide® and Symbicort® (separated by 24 hours).

  In order to generate the data required for this study, a technique called gamma scintigraphy imaging will be used. Gamma scintigraphy is an imaging technique for detecting and quantifying a radiolabelled tracer inside the body which can track how a drug is distributed in the body.

  The study will involve the following:
  - Screening Visit
  - CT Scan Visit
  - 3 Imaging Periods (around 4 days in duration combined)
  - Post-Study Follow-Up Telephone Call

  With respect to the conduct of the study, the screening procedures (including CT scan visit) and follow up telephone call will be conducted by Medimprove BV, based in Belgium with all participants to be screened and recruited in Belgium and the 3 gamma scintigraphy imaging periods will be conducted at the Simbec-Orion Clinical Pharmacology Unit in the UK.
  

• REC name

  Wales REC 2

• REC reference

  25/WA/0193

• Date of REC Opinion

  16 Jul 2025

• REC opinion

  Favourable Opinion