Blood levels of inhaled fluticasone and salmeterol v1
Research type
Research Study
Full title
A Pharmacokinetic Study in Healthy Subjects Following Single Dose Oral Inhalation of Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Combinations (HMR study: 16-004). \n
IRAS ID
202509
Contact name
Adeep Puri
Contact email
Sponsor organisation
Oriel Therapeutics
Eudract number
2016-000670-37
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Salmeterol xinafoate (salmeterol) and fluticasone propionate (fluticasone) are 2 medicines widely prescribed to prevent asthma attacks. 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 (irritation) in the airways. \n\nAsthma patients take salmeterol and fluticasone together from a single inhaler called Seretide Accuhaler (in the UK) or Advair Diskus (in the USA). The usual dose is 1 inhalation, once or twice a day.\n\nIn this study, we’ll ask up to 36 healthy men and women, aged 18–50, to take doses of salmeterol and fluticasone using the Advair Diskus inhaler. On 2 occasions, they’ll take the usual dose (1 inhalation: 50 micrograms salmeterol with 100 micrograms fluticasone); on the other 2 occasions, they’ll take three times the usual dose (3 inhalations: 150 micrograms salmeterol with 300 micrograms fluticasone). We’ll compare blood levels of salmeterol and fluticasone after each dose; the results will help to design future studies of inhaled medicines. \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. \n\nA pharmaceutical company, Oriel Therapeutics Inc, is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
16/NI/0040
Date of REC Opinion
31 Mar 2016
REC opinion
Favourable Opinion