RE: My Pirfenidone Trial Update (Angie)

[Guest guest]

Angie,

The Pirfenidone Capacity and Open Label

Trials are run by Intermune the drug company with USA

rights to the drug, I’m participating through Beth

Israel Deaconess

Medical Center

located in Boston, MA

which is affiliated with Harvard

University School

of medicine. The Capacity trial has been closed for over a year and the

Open Label trial is only open to those that complete the Capacity trial. The

Capacity trial included 720 patients and 125 international centers.

Link to Capacity trial http://www.capacitytrials.com/wt/page/index

Link to Beth Israel

Deaconess Medical

Center Interstitial

Lung Disease

Center http://bidmc.harvard.edu/ild

I hope this answers your question

Ken Baker UIP/IPF 12/05 New Hampshire

From: Breathe-Support [mailto:Breathe-Support ] On Behalf Of angie roman

Sent: Tuesday, September 23, 2008

9:27 PM

To: Breathe-Support

Subject: Re: My

Pirfenidone Trial Update

HI , WHERE IS

THE PIRFENIDONE TRIAL?

Angie

From: Ken Baker <ridgerunnernh (AT) comcast (DOT) net>

Subject: My Pirfenidone Trial Update

To: Breathe-Support

Date: Tuesday, September 23, 2008, 9:30 AM

I promised to keep both the Breathe

Support and PFF groups updated on my

results in the Pirfenidone drug trial so here is the latest update which I

will post to both groups. I wont find out if I was on the real medicine or

placebo until all participants in the capacity study have completed (maybe

Jan 2009).

September 22, 2008 The Pirfenidone Capacity trial is over for me and today

I began the open label pirfenidone study. I had a PFT to commemorate

the

occasion and the results were slightly improved from the last one. My

FVC

was 4.22 (92% of predicted) my FEV1 was 3.42 (109% of predicted) and best

of all my DsbHb (DLCO) was 18.51 (71% of predicted). I'm continuing to

function without the use of supplemental oxygen except under pretty intense

exercise (like treadmill over 3.6MPH at 10% elevation). I'm able to

complete 40 minutes on the treadmill at 10% elevation walking at 3.4MPH

with my saturation staying right at 90. I can go up to 4.0MPH but my

saturation falls into the mid to low 80's.

In the Open Label study I get the real medicine so I'm ramping up to full

dosage over the next three weeks. Starting with 1 capsule three tines a

day for the first week increasing to 2 capsules three times a day the

second week and finally up to 3 capsules three times a day from then on.

As I have posted before I was initially diagnosed in Dec 2005 and had a

confirming VATS biopsy in Oct 2006. I entered the Pirfenidone Capacity

drug trial Feb 2007 and the Open label drug trial Sep 2008.

Ken Baker UIP/IPF 12/05 New

Hampshire