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Asthma/COPD

If you are planning to run a respiratory trial, then BioKinetic Europe can provide you with the expertise, specialist help and advice you need. Supported by the wealth of experience brought by our medical and nursing teams, Specialist Consultants and Primary Care Physicians; together with our extensive volunteer database, means your study will be filled and completed to exacting standards.

respiratory healthWe have extensive experience in over 400 clinical trials, including studies using pMDIs, DPIs, primed spacers and other inhalation devices and drug delivery systems.  We have completed studies measuring Inspiratory Flow Rate and FEV, and our staff are fully trained and experienced in research and clinical spirometry. 

The range of studies already completed include:

  • A validated method for pulmonary vs. systemic deposition of an inhaled drug.
  • A drug for Cystic Fibrosis which investigated different delivery systems via various nebulisers and a novel-inhaled computer-controlled delivery system with accurate flow rate.
  • The safety, tolerance and rate and level of absorption of an investigational new drug being examined for the treatment of asthma 1 group - 1 period.
  • A study to determine the total amount of drug in the bloodstream after administration via two different methods using a metered dose inhaler with & without a spacer.
  • A randomised, open-label, cross-over study of inhaler devices in adolescents and adults with persistent asthma or COPD to assess patient handling.

For Phase II/III studies we can recruit subjects via effective targeted advertising campaigns and/or the GP Network of Primary Care Physicians in Northern Ireland (NI). We have a strong working relationship with over 25 GP Centres, whose physicians and practice nurses are GCP trained and experienced in the conduct of commercial clinical trials. The advantage of this unique operating environment is that the NI GP Network is not subject to Health Service governance and subsequent timeline lags like the rest of the UK. The MHRA have routinely approved Phase II CTAs in 30 days and the Ethics Committee meets twice a month for Phase II studies with a 14 day timeline for approval.

How does it work?

  • Feasibility & Study Award

  • Regulatory approvals

  • Trial conduct

  • Database lock, review of CSR, study close-out