A Pilot PD/PK Study of Advair for model development

• Research type

  Research Study

• Full title

  A Pilot Pharmacodynamic/Pharmacokinetic Study of Salmeterol Xinofoate as a Dry Powder in Combination with Fluticasone in Patients with Asthma for Dose-Scale Bronchodilator Model Development

• IRAS ID

  46836

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2010-018712-32

• ISRCTN Number

  xx

• Research summary

  Preparations containinfluicasone and Salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. During this study subjects will receive the product approved in the US (Advair© Diskus©). This is identical in all but name to the product approved in the UK (Seretide© Accuhaler©). The data obtained from this current study will be used by the sponsor in the development of new inhalers. To reduce the need for lengthy time consuming studies, Regulatory Authorities (such as the FDA (Food and Drug Administration) in the US) are happy for sponsor companies to establish new experimental models that show new inhaler devices deliver equivalent dose levels of drug to the lungs and have similar effectiveness as current marketed devices. In this study we will investigate the effects of 3 different doses of Advair© Diskus© on various lung function parameters in conjunction with blood concentrations of the drug. The data obtained from this study will be incorporated in to future studies investigating new asthmatic drug preparations. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 30 asthmatic volunteers will participate in the trial. Each volunteer will attend the unit for three admission periods each lasting 3 days.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/18

• Date of REC Opinion

  1 Mar 2010

• REC opinion

  Favourable Opinion