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Clinical Trials in IPF

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

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  1. Clinical Trials in IPF Dr Helen Parfrey

  2. 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

  3. 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

  4. Have you taken part in a clinical trial for IPF?

  5. Exciting time for IPF

  6. 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)

  7. 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

  8. 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

  9. 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

  10. New treatments - Pirfenidone Noble PW et al, Lancet 2011

  11. 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

  12. 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

  13. 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

  14. Current Clinical Trials in IPF 116 studies in IPF 22 therapeutic trials

  15. 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

  16. 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

  17. Thank you for participating in the studies

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