Bioequivalence of two strengths of two inhalers with spacer (114190)

• Research type

  Research Study

• Full title

  Phase I open label randomized cross-over study in healthy male and female volunteers to demonstrate the bioequivalence of each of two strengths of two pressurized metered dose inhalers that deliver 25 mcg Salmeterol (as Salmeterol Xinafoate) and 125 or 250 mcg Fluticasone Propionate per actuation when administered with the aid of the AeroChamber Plus spacer

• IRAS ID

  110003

• Contact name

  Joanne Collier

• Sponsor organisation

  3M Drug Delivery Systems Division

• Eudract number

  2012-002186-35

• Research summary

  The goal of this study is to compare two inhalers delivering a steroid / long acting beta agonist combination of two different strengths with the aid of a spacer. The study population will be healthy male and female volunteers. Study will be conducted at a Phase I Clinical research Organisation and each volunteer is expected to participate for 2-5 weeks in the trial.

• REC name

  HSC REC B

• REC reference

  12/NI/0101

• Date of REC Opinion

  6 Aug 2012

• REC opinion

  Further Information Favourable Opinion