Blood levels of inhaled fluticasone and salmeterol; v1
Research type
Research Study
Full title
An Assessment of Pharmacokinetic Bioequivalence in Healthy Subjects of Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Combinations Administered as OT329 Solis™ 100/50 versus Advair Diskus® 100/50\n
IRAS ID
215852
Contact name
Adeep Puri
Contact email
Sponsor organisation
Oriel Therapeutics
Eudract number
2016-003920-22
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Salmeterol xinafoate (salmeterol) and fluticasone propionate (fluticasone) are 2 medicines commonly used to prevent attacks of asthma. People with asthma find it difficult to breathe, because the small tubes that carry air in and out of the lungs become narrow. Salmeterol works by relaxing the muscles in the airways, making breathing easier. Fluticasone also makes breathing easier, but it works mainly by reducing swelling and inflammation in the airways. Asthma patients take salmeterol and fluticasone (the study medicines) together from a single inhaler called Seretide Accuhaler (in the UK) or Advair Diskus (in the USA). \n\n\nWe’re doing this study, in healthy volunteers, to compare Advair Diskus with a new inhaled product, called OT329 Solis (called Solis from now on). We aim to find out whether Solis and Advair Diskus give similar blood levels of the study medicines. If they do, Solis might be a cheaper alternative to existing asthma treatments because it’s being developed as a ‘generic’ – a product that’s the same as one that’s already available. \n\nWe’ll give up to 60 healthy men and women, aged 18–50, 4 doses of 150 micrograms salmeterol with 300 micrograms fluticasone). On 2 occasions, they’ll take a dose from Solis; on the other 2 occasions, they’ll take a dose from Advair Diskus. We’ll compare blood levels of salmeterol and fluticasone after each dose. \nParticipants will take up to 11 weeks to finish the study. They’ll make 1 outpatient visit and have 4 study sessions. In each study session they’ll stay on the ward for 3 nights in a row. \n\nA pharmaceutical company, Oriel Therapeutics Inc, is funding the study.\n\nThe study will take place at 1 centre in London.\n\n\n
REC name
HSC REC B
REC reference
16/NI/0207
Date of REC Opinion
17 Oct 2016
REC opinion
Favourable Opinion