Bioequivalence of each of three strengths of two dosed inhalers

• 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 Three Strengths of Two Pressurized Metered Dose Inhalers that Deliver 25mcg Salmeterol (as Salmeterol Xinafoate) and 50, 125, 250 mcg Fluticasone Propionate per Actuation when Administered with the Aid of the AeroChamber Plus Spacer

• IRAS ID

  95012

• Contact name

  Joanne Collier

• Sponsor organisation

  3M Drug Delivery Systems Division (DDSD)

• Eudract number

  2011-005415-93

• Research summary

  The goal of this study is to compare two inhalers delivering a steroid / long acting beta agonist combination of three 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 2-4 weeks in the trial.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0187

• Date of REC Opinion

  17 Jan 2012

• REC opinion

  Further Information Favourable Opinion