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 code (16-030)
IRAS ID
218127
Contact name
Adeep Puri
Contact email
Sponsor organisation
Oriel Therapeutics Inc
Eudract number
2016-004428-52
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Salmeterol xinafoate (salmeterol) and fluticasone propionate (fluticasone) are 2 medicines that are 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 reduces swelling and inflammation, making it easier to breathe. 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\nPrevious studies have shown that levels of those medicines in the blood, when taken from the Advair Diskus inhaler, may vary depending on the batch of inhaler used. We’re doing this study to compare how much of the study medicines gets into the blood after using Advair Diskus inhalers from the same batch and from different batches. We hope that investigating that will help the development of future salmeterol/fluticasone inhalers. \n\nWe’ll give up to 48 healthy men and women, aged 18 to 50, 3 doses of 300 micrograms fluticasone and 150 micrograms salmeterol. On 2 occasions, they’ll take a dose from the same batch of Advair Diskus. On the other occasion, they’ll take a dose from a different batch of Advair Diskus. We’ll compare blood levels of salmeterol and fluticasone after each dose.\n\nParticipants will take up to 9 weeks to finish the study. They’ll have 1 outpatient visit and 3 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.
REC name
HSC REC A
REC reference
16/NI/0241
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion