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Clinical Trials in IPF. Dr Helen Parfrey. Are clinical trials needed ?. Essential to determine if a drug therapy is beneficial Identify who will benefit the most from the treatment Side effects associated with the drug therapy Information about the disease.

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clinical trials in ipf

Clinical Trials in IPF

Dr Helen Parfrey

are clinical trials needed
Are clinical trials needed ?
  • Essential to determine if a drug therapy is beneficial
  • Identify who will benefit the most from the treatment
  • Side effects associated with the drug therapy
  • Information about the disease
how to determine if a drug treatment is effective
How to determine if a drug treatment is effective?
  • “Controlled” - compare the drug treatment to a placebo
  • “Blinded” - the study co-ordinators and patients do not know what treatment has been given
  • “Endpoints” - markers to indicate if the drug is beneficial
    • IPF trials use lung function tests (FVC), hospital admissions, survival, quality of life, measures of breathlessness
  • “Powered” - sufficient number of patients
  • “Inclusion and exclusion criteria” – how to select patients for a study
but several studies have shown that the treatments have not been effective for ipf
But, several studies have shown that the treatments have not been effective for IPF
  • Interferon gamma studies (INSPIRE)
  • Bosentan studies (BUILD series)
  • Anti-TNFα studies (Etanercept)
  • Tyrosine kinase inhibitor (Imatinib)
triple therapy ifigenia study
Triple therapy: IFIGENIA study

Limitations

All patients in the study taking prednisolone and azathioprine

Not compare treatment with N-acetylcysteine alone with placebo

Demedts et al New Engl J Med 2005

interim safety analysis panther ipf
Interim safety analysis: PANTHER-IPF
  • Phase III trial, double blind placebo controlled to assess effectiveness of NAC
  • Recruited 238 out of 390 patients with mild to moderate IPF
  • Patient enrolment into Pred/Aza/NAC ceased
anticoagulation therapy for ipf
Anticoagulation therapy for IPF
  • Limitations
  • Small number of patients
  • Not blinded
  • High drop out in treatment group
  • No exclusion of PE as cause for deterioration

Kubo et al, Chest 2005

new treatments pirfenidone
New treatments - Pirfenidone

Noble PW et al, Lancet 2011

cochrane review of pirfenidone studies
Cochrane Review of Pirfenidone Studies
  • First licensed treatment for mild to moderate IPF
    • FVC≥50%, TLCO≥35%, 6MWD ≥150m
  • Named patient programme
  • NICE evaluation currently
clinical trial
Clinical Trial
  • Tyrosine kinase inhibitor BIBF 1120
    • Phase II trial, placebo controlled, 432 patients with IPF

Richeldi L et al New Engl J Med 2011

how to find out about clinical trials in ipf
How to find out about clinical trials in IPF?
  • Ask your hospital doctor
  • Clinicaltrials.gov website
    • Details of clinical trials in all areas of medicine
    • Use search function to look for trials related to IPF
current clinical trials in ipf
Current Clinical Trials in IPF

116 studies in IPF

22 therapeutic trials

on going clinical trials
On-going clinical trials
  • BIBF 1120
  • QAX576
  • Thalidomide
  • Sildenafil
  • Plasma exchange, rituximab and steroids for acute exacerbations
  • Sirolimus
  • Losartan
  • Phase I
    • AB0024
    • PRM-151
    • STX-100
    • CC930
    • IW001

Clinicaltrials.gov

summary
Summary
  • Importance of clinical trials in evaluating new treatments for IPF
  • Carefully designed
  • Expotential increase in clinical trials for IPF
  • Change how IPF is treated
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