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ILD research in Wessex
WILD meeting 9th October 2017
Dr Chris Brereton
Outline
• Current research trials
– EME-TIPAC (IPF)
– MA39189 (unclassified fibrosis)
– Exercise in IPF
• Upcoming research trials
– Zephyr (IPF)
– Celegene (IPF)
– IPF JES
– TRAIL1 (rheumatoid arthritis-ILD)
– Time to diagnosis in IPF
EME-TIPAC
• Efficacy and Mechanism Evaluation of Treating
IPF with addition of Co-trimoxazole
• Co-trimoxazole (septran) a broad spectrum
antibiotic.
• Eligible patients
– Moderate to severe IPF
– CAN be on other treatments
(nintedanib/pirfenidone)
EME-TIPAC
• Participants are randomised to drug or placebo.
• Undertake treatment for between 12 and 42
months.
• Hospital visits at 6 weeks, 3 months, 6 months, 9
months and then every 6 months
• Clinical questionnaires, bloods tests and lung
function.
• 6 participants in Wessex so far. Need another
two.
MA39189
• Pirfenidone in patients with unclassifiable
progressive pulmonary fibrosis
• Randomised to drug versus placebo and
treated for 24 weeks (total study treatment 91
weeks including open label safety follow up)
• 10 hospital visits (plus more if moving to open
label follow up)
• Looking for at least 2 participants
Exercise in IPF
• 8 week exercise program for patients with
mild to moderate IPF (feasibility study)
• Structured cycling-based training program
tailored individually for each patient’s fitness
level
• Also involves blood tests, lung function,
questionnaires
Exercise in IPF
• Looking for 6 participants
• Training at UHS (40 minutes, twice weekly for
8 weeks)
• Car parking and petrol can be reimbursed
Zephyr
• GBT-440 on hypoxaemia in subjects with IPF
using supplemental oxygen at rest
• Eligible participants
– Requiring supplemental oxygen at rest
– Able to walk 100 metres
– CAN be on pirfenidone/nintedanib
• All patients will receive the drug (no placebo)
Zephyr
• 8 hospital visits over 151 days
• Patients will need to undergo lung function
tests, 6 minute walk tests, blood tests and
questionnaires
• Also oxygen titration tests and arterial blood
gas.
TRAIL1
• Tolerability and efficacy of pirfenidone in
rheumatoid arthritis ILD
• Randomised to drug versus placebo
• Study duration 15 months (treatment for 12
months)
• Looking for 6-8 participants
• Eligible participants will have 8 hospital visits,
a CT chest, lung function, blood tests
IPF-JES
• IPF Job exposure study
• Looking to measure asbestos exposure in
participants diagnosed with IPF (i.e.
Questionairre over the phone)
• Also looking at genetic interactions with
asbestos (i.e. Blood test)
• Eligible patients – not worked outside UK for
more than 1 year
• Looking for 30 recruits.
Celegene
• Evaluating CC-90001 in IPF
• 24 weeks randomised to drug (two different
doses) versus placebo
• Followed by 28 week treatment extension of
blinded study drug
• Between 9 and 15 hospital visits
• Eligible participants
– Mild-moderate IPF
– NOT on pirfenidone/nintedanib
Time to diagnosis and treatment in IPF
• Measuring the time between referral by GP
and final diagnosis/treatment
• Comparing this length of time to outcomes
• De-identification and review of medical
records for all patients diagnosed with IPF in
past 5 years
Some final points
IDL RESEARCH IN WESSEX
IDL RESEARCH IN WESSEX
IDL RESEARCH IN WESSEX

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IDL RESEARCH IN WESSEX

  • 1. ILD research in Wessex WILD meeting 9th October 2017 Dr Chris Brereton
  • 2.
  • 3. Outline • Current research trials – EME-TIPAC (IPF) – MA39189 (unclassified fibrosis) – Exercise in IPF • Upcoming research trials – Zephyr (IPF) – Celegene (IPF) – IPF JES – TRAIL1 (rheumatoid arthritis-ILD) – Time to diagnosis in IPF
  • 4. EME-TIPAC • Efficacy and Mechanism Evaluation of Treating IPF with addition of Co-trimoxazole • Co-trimoxazole (septran) a broad spectrum antibiotic. • Eligible patients – Moderate to severe IPF – CAN be on other treatments (nintedanib/pirfenidone)
  • 5. EME-TIPAC • Participants are randomised to drug or placebo. • Undertake treatment for between 12 and 42 months. • Hospital visits at 6 weeks, 3 months, 6 months, 9 months and then every 6 months • Clinical questionnaires, bloods tests and lung function. • 6 participants in Wessex so far. Need another two.
  • 6. MA39189 • Pirfenidone in patients with unclassifiable progressive pulmonary fibrosis • Randomised to drug versus placebo and treated for 24 weeks (total study treatment 91 weeks including open label safety follow up) • 10 hospital visits (plus more if moving to open label follow up) • Looking for at least 2 participants
  • 7. Exercise in IPF • 8 week exercise program for patients with mild to moderate IPF (feasibility study) • Structured cycling-based training program tailored individually for each patient’s fitness level • Also involves blood tests, lung function, questionnaires
  • 8. Exercise in IPF • Looking for 6 participants • Training at UHS (40 minutes, twice weekly for 8 weeks) • Car parking and petrol can be reimbursed
  • 9.
  • 10. Zephyr • GBT-440 on hypoxaemia in subjects with IPF using supplemental oxygen at rest • Eligible participants – Requiring supplemental oxygen at rest – Able to walk 100 metres – CAN be on pirfenidone/nintedanib • All patients will receive the drug (no placebo)
  • 11. Zephyr • 8 hospital visits over 151 days • Patients will need to undergo lung function tests, 6 minute walk tests, blood tests and questionnaires • Also oxygen titration tests and arterial blood gas.
  • 12. TRAIL1 • Tolerability and efficacy of pirfenidone in rheumatoid arthritis ILD • Randomised to drug versus placebo • Study duration 15 months (treatment for 12 months) • Looking for 6-8 participants • Eligible participants will have 8 hospital visits, a CT chest, lung function, blood tests
  • 13. IPF-JES • IPF Job exposure study • Looking to measure asbestos exposure in participants diagnosed with IPF (i.e. Questionairre over the phone) • Also looking at genetic interactions with asbestos (i.e. Blood test) • Eligible patients – not worked outside UK for more than 1 year • Looking for 30 recruits.
  • 14.
  • 15. Celegene • Evaluating CC-90001 in IPF • 24 weeks randomised to drug (two different doses) versus placebo • Followed by 28 week treatment extension of blinded study drug • Between 9 and 15 hospital visits • Eligible participants – Mild-moderate IPF – NOT on pirfenidone/nintedanib
  • 16. Time to diagnosis and treatment in IPF • Measuring the time between referral by GP and final diagnosis/treatment • Comparing this length of time to outcomes • De-identification and review of medical records for all patients diagnosed with IPF in past 5 years
  • 17.