Blood levels of inhaled fluticasone and salmeterol
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® 500/50 versus Advair Diskus® 500/50 (HMR code: 19-012)
IRAS ID
270880
Contact name
Elise Burmeister Getz
Contact email
Sponsor organisation
Oriel Therapeutics Inc.
Eudract number
2019-003423-38
Duration of Study in the UK
1 years, 0 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, and fluticasone relieves swelling and inflammation (irritation), making it easier to breathe. People who suffer from asthma 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\nWe’re doing this study in healthy volunteers to compare Advair Diskus with a new inhaler, OT329 Solis (called Solis from now on). Solis is being developed as a ‘generic’ – a product that’s similar to one that’s already available. We aim to find out whether several different batches of Solis and Advair Diskus inhalers give similar blood levels of the study medicines. If they do, Solis might be a cheaper alternative to existing asthma treatments.\n\nWe’ll give up to 96 healthy men and women, aged 18–50 years, 4 doses of 500 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 10 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
19/LO/1481
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion