Determination of the pharmacokinetics of inhaled mannitol

• Research type

  Research Study

• Full title

  Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in Cystic Fibrosis patients

• Sponsor organisation

  Pharmaxis

• Eudract number

  2008-008228-34

• ISRCTN Number

  Unknown

• Research summary

  In cystic fibrosis (CF) the airways contain thick, sticky mucus which is difficult to clear from the lungs. This mucus provides both an ideal environment for the growth of bacteria and clogs the airways, making it more difficult to breathe. The most important treatments for patients with CF are aimed at controlling bacterial lung infection with antibiotics, reducing the amount of mucus in the lungs, and regular physiotherapy.Thinning the mucus helps the lung??s normal clearance mechanism (known as mucociliary clearance) to work so physiotherapy can be more effective. An inhalable dry powder mannitol (hereafter referred to as Ó?mannitol?) is an investigational medication which can thin lung mucus. Short-term studies in adults with CF and in adults with another lung disease known as bronchiectasis (similar to CF) have shown that mannitol thins the mucus by increasing the water content in the airways, allowing it to be coughed up with greater ease. Long term studies of mannitol in CF are currently underway.Mannitol is a naturally occurring sugar found in fruit and vegetables, and has been used as a food sweetener and a medicine for many years. It can be given intravenously to prevent and treat kidney failure, reduce high pressure in the brain (cerebral oedema), and as a drink to prepare the intestine for surgery. It works by osmosis; it draws excess water from the tissues, allowing excesflud to be naturally excreted by the body. In a similar manner, inhaling a specially prepared dry powdered form of mannitol causes water to be drawn from the lung tissues out onto the inner surface where it wets and thins the mucus. The mucus can then be coughed up more easily. This studies primary aim is to understand how much mannitol is found in the blood stream after if has been inhaled.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/11

• Date of REC Opinion

  14 Apr 2009

• REC opinion

  Further Information Favourable Opinion