Clinical trials in ipf
Download
1 / 18

Clinical Trials in IPF - PowerPoint PPT Presentation


  • 248 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' Clinical Trials in IPF' - megan


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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 been effective for IPF

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 been effective for 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 been effective 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 been effective for IPF

Noble PW et al, Lancet 2011


Cochrane review of pirfenidone studies
Cochrane Review of Pirfenidone Studies been effective for IPF

  • First licensed treatment for mild to moderate IPF

    • FVC≥50%, TLCO≥35%, 6MWD ≥150m

  • Named patient programme

  • NICE evaluation currently


Clinical trial
Clinical Trial been effective for IPF

  • 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? been effective for 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 been effective for IPF

116 studies in IPF

22 therapeutic trials


On going clinical trials
On-going clinical trials been effective for IPF

  • 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 been effective for IPF

  • Importance of clinical trials in evaluating new treatments for IPF

  • Carefully designed

  • Expotential increase in clinical trials for IPF

  • Change how IPF is treated



ad