PK study of Fluticasone/Salmeterol combinations (329/209)
Research type
Research Study
Full title
A Phase I Pilot Pharmacokinetic Study in Healthy Subjects of Fluticasone Propionate/Salmeterol Xinafoate Combinations Administered as Dry Powders in Solis™ versus Diskus®
IRAS ID
136482
Contact name
Leonard Siew
Contact email
Sponsor organisation
Oriel Therapeutics Inc
Eudract number
2013-003071-35
Research summary
The purpose of this study is to assess the timecourse (rise and fall) of the concentrations of fluticasone and salmeterol in the blood following a single dose of fluticasone/salmeterol dry powder combinations administered by Solis™ inhaler and Advair® Diskus® via oral inhalation in healthy volunteers. \n\nPreparations containing fluticasone and salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. During this study, subjects will receive the combination medication via 2 products, US approved Advair® Diskus® and the test product OT329 Solis™. \n\nThe study will take place at Quintiles Drug Research Unit at Guy’s Hospital. At least 24 volunteers will be allocated to treatment to ensure 20 volunteers complete the study.\n\nEach volunteer will participate in 4 treatment periods, each period lasting 4 days (3 nights). In each treatment period volunteers will receive a single dose of study medication. Each dose will be separated by at least 7 days. The discharge of the last treatment period will also be the final follow up. \nAt least one and not more than three OT329 Solis™ treatments and at least one and not more than three Advair® Diskus® treatment will be administered over the course of the study. Blood samples for determination of the level of the study drug in the blood will be collected in each treatment period at various time-points pre-dose and post-dose.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0250
Date of REC Opinion
19 Sep 2013
REC opinion
Further Information Favourable Opinion