Inhaled GMP grade Lipopolysaccharide in healthy non smokers

• Research type

  Research Study

• Full title

  Dose ranging study to evaluate the effects of a new formulation of inhaled Lipopolysaccharide (LPS) in Healthy Volunteers

• IRAS ID

  132360

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Medicines Evaluation Unit Ltd

• Research summary

  The purpose of this study is to administer Lipopolysaccharide (LPS) by inhalation to monitor irritation in the lungs. LPS is a bacterial component, which has been used in many other studies to cause a short-lived immume response by the body. In this study we are interested in the response of the lungs to LPS in Healthy participants. Volunteers given LPS by inhalation all recover fully within 24hours. LPS in previous studies has been safely given to healthy volunteers that were both smokers and non smokers, and to patients with asthma and COPD. The purpose of the study is to administer LPS and analyse the sputum (phlegm) to assess the inflammatory cells in the lungs.
  In this study new GMP grade Lipopolysaccharide (LPS) will be administered by inhalation to healthy subjects in order to determine the dose that safely causes neutrophiic airway inflammation. This LPS batch has never been given to humans before, so we will conduct a dose ascending study to evaluate its safety and pro-inflammatory effects.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  13/NW/0482

• Date of REC Opinion

  13 Jul 2013

• REC opinion

  Favourable Opinion