An AMP challenge study of escalating repeat doses of FF, FP and BUD
Research type
Research Study
Full title
An escalating dose, randomized, placebo-controlled, incomplete block, 2-period cross-over study to assess the dose response for topical efficacy via airway responsiveness to adenosine-5’-monophosphate (AMP) challenge and the dose response for systemic activity via 24h plasma cortisol suppression and thereby the relative therapeutic index for fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD) in asthmatic subjects.
IRAS ID
211635
Contact name
Charlotte Maden
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-003002-14
Duration of Study in the UK
0 years, 8 months, 17 days
Research summary
The main purpose of this study is to look at how different levels of different medications called inhaled corticosteroids (ICS) affect the lungs of people with Asthma. ICS drugs are a common treatment for asthma and have an anti-inflammatory affect in the airways of the lungs. \nThis study will compare two different licensed medications (medications which can be prescribed by GPs), and a medication which has not yet been licensed for use in the UK (licensed in USA and 5 other countries):\n•\tFluticasone Furoate, using the ELLIPTA™ inhaler (not currently available in the UK)\n•\tFluticasone Propionate, using the DISKUS™ inhaler (available in the UK)\n•\tBudesonide, using the Turbuhaler inhaler (available in the UK)\n\nUp to two of these medications will be given in increasing dose levels, over two Treatment Periods, each lasting approximately five weeks. A medical test called an AMP challenge will be performed at various time points in order to look at the anti-inflammatory effects of these medications. During an AMP challenge, subjects inhale adenosine-5’-monophosphate (AMP), a substance which causes the airways to narrow and subjects will feel the usual symptoms of asthma e.g. chest tightness and cough. \nSubjects may receive Fluticasone Furoate placebo or Fluticasone Propionate placebo. There will be a washout period (where no study drugs are given) between the two treatment periods lasting approximately 25 to 42 days.\nIt is anticipated that approximately 48 subjects will be randomised to this study, over two UK sites.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0781
Date of REC Opinion
13 Dec 2016
REC opinion
Further Information Favourable Opinion