PD dose responses of inhaled Salmeterol and Fluticasone Propionate

• Research type

  Research Study

• Full title

  Phase I Modified Single Blind (Subject Blinded to Device and Analyst Blinded for all Assessments), Randomised, Placebo-controlled Five-period Incomplete Block Study in Healthy Male and Female Volunteers to Demonstrate the Comparability of the Pharmacodynamic Dose Responses of the Salmeterol Component of Two Pressurized Metered Dose Inhalers that Deliver 25 mcg Salmeterol (as Salmeterol Xinafoate) and 125 mcg Fluticasone Propionate per Actuation

• IRAS ID

  92103

• Contact name

  Arpeat Kaviya

• Sponsor organisation

  3M Drug Delivery Systems Division (DDSD)

• Eudract number

  2011-005105-67

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The goal of this study is to compare the safety profiles and effect of the drug on the body of two products that deliver 25 mcg Salmeterol (as Salmeterol Xinafoate) and 125 mcg Fluticasone Propionate per actuation. The test product is a new formulation manufactured by 3M Drug Delivery Systems Division (DDSD). The reference product is commercially available as Seretide- Evohaler- .

• REC name

  North East - York Research Ethics Committee

• REC reference

  11/NE/0333

• Date of REC Opinion

  14 Dec 2011

• REC opinion

  Further Information Favourable Opinion