Blood levels of inhaled fluticasone and salmeterol; version 1
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® 250/50 versus Advair Diskus® 250/50 (HMR code:17-013)\n
IRAS ID
236481
Contact name
Adeep Puri
Contact email
Sponsor organisation
Oriel Therapeutics Inc.
Eudract number
2017-004077-14
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Fluticasone propionate (fluticasone) and Salmeterol xinafoate (salmeterol) are 2 medicines commonly used to prevent asthma attacks. People with asthma have difficulty breathing because the small tubes that carry air in and out of the lungs become narrow. Salmeterol works by relaxing the muscles in the airways, and fluticasone relieves swelling and inflammation (irritation), making it easier to breathe. People who suffer from asthma take fluticasone and salmeterol (the study medicines) together from a single inhaler called Seretide Accuhaler (in the UK) or Advair Diskus (in the USA).\n\nWe’re doing this study, in healthy volunteers, to compare Advair Diskus with a new experimental inhaler 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 96 healthy men and women, aged 18–50 years, 4 doses of 250 micrograms fluticasone and 50 micrograms salmeterol. On 2 occasions, they’ll take a dose using the Advair Diskus inhaler. On the other 2 occasions, they’ll take a dose using the Solis inhaler. We’ll compare blood levels of salmeterol and fluticasone after each dose.\n\nParticipants will take up to 7 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
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1893
Date of REC Opinion
5 Jan 2018
REC opinion
Further Information Favourable Opinion