Guest guest Posted October 29, 2006 Report Share Posted October 29, 2006 Stu, I received the notice (invitation and consent form) in the mail this past Monday and it has an approved stamp by Beth Israel Deaconess Hospital (where I just had my biopsy to qualify). I'm expecting to get an update on getting started after my pulmonary reviews the biopsy results this week. The notice I received is an " Informed consent form to take part in a research study " so I assume that " I am in " . My Pulmonary was out all last week but the office said he would be contacting me this coming week. The lack of a biopsy was the only limiting factor we discussed at the last visit. I have downloaded two documents from the American Journal of Respiratory and Critical care (http://ajrccm.atsjournals.org/) which have the results of a couple of phase II studies. One is back in 1998 the other is from 2004. I found them by simple search using pirfenidone as a keyword on the above website. The 1998 is an FDA study and the 2004 is from Japan. I can't believe it has taken so long to get the Phase III studies started. Ken Baker UIP/IPF 12/2005 > > Is there anybody that is in the Pirfenidone experimental drug study or > is in the process of qualifying for it ? > > Stu IPF 8/06 > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 29, 2006 Report Share Posted October 29, 2006 Hi Ken, I have filled out all of the paperwork to get into the study and am now in the 28 day " lung drug " free phase. I was taking Prednisone but the study requires you to have not taken any lung drugs for 28 days. I then go in for a day of tests to see if I can qualify for the study. The study wants you to be sick, but not too sick! Here is a link to FDA approved drug studies concernng IPF: http://www.clinicaltrials.gov/ct/search;jsessionid=147EE69180949986EAA B63B93DA6A2AD?term=IPF & submit=Search You'll see two listed for Pirfenidone. The info includes the acceptance critiria: Here are the names of the two studies: 1. Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis 2. Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis I am trying to get into the second one. The first one has a 50% placebo and the second has a 40% placebo. The study lasts 60 weeks. Now, concerning why it has taken so long to get this drug to Phase III. My doc told me that Pirfenidone was developed by a small company in Japan. At about the same time, InterMune, an American company, developed a competing drug. InterMune bought out the Japanese company and put the research of Pirfenidone " on the back burner " because it was finanacially beneficial to InterMune to try to get their drug approved. When their drug did not look promising they switched thier efforts to Pirfenidone. Hence, the long time delay. btw, thanks for the link o the two research papers. Stu IPF 8/06 > > > > Is there anybody that is in the Pirfenidone experimental drug study or > > is in the process of qualifying for it ? > > > > Stu IPF 8/06 > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 29, 2006 Report Share Posted October 29, 2006 , I'm not surprised you feel better on the liquid vs the conserver. Your saturations are probably much improved. I remember reading somewhere (can't remember where so I can't swear to it) that folks like us with restrictive lung disease (as opposed to something like COPD which is obstructive lung disease) in general do better with continuous flow O2 especially in the later stages of the disease. Hope you find out what you need to about the lift chair. If it would make your life easier and less stressful, it's probably a good idea! Don't get too discouraged about timelines and the number of years that people live. We're all different and no one can tell how long someone will live. It's truly not for us to say or even guess at. My own grandmother was given 8 weeks when she had cancer and she lived 3 years! She used to laugh at the oncologist because he just couldn't figure it out. Concentrate on making yourself comfortable and content. Take care of yourself, get enough O2, eat well and do what you need to do to keep your spirits up. We're all here anytime you need us! Beth (Fibrotic NSIP 06/06)Draw close. Hold hands. Life is short. God is good. Re: Pirfenidone study Hi Ken,I have filled out all of the paperwork to get into the study and am now in the 28 day "lung drug" free phase. I was taking Prednisone but the study requires you to have not taken any lung drugs for 28 days. I then go in for a day of tests to see if I can qualify for the study. The study wants you to be sick, but not too sick!Here is a link to FDA approved drug studies concernng IPF:http://www.clinical trials.gov/ ct/search; jsessionid= 147EE69180949986 EAAB63B93DA6A2AD? term=IPF & submit=SearchYou'll see two listed for Pirfenidone. The info includes the acceptance critiria:Here are the names of the two studies:1. Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis2. Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisI am trying to get into the second one. The first one has a 50% placebo and the second has a 40% placebo.The study lasts 60 weeks.Now, concerning why it has taken so long to get this drug to Phase III. My doc told me that Pirfenidone was developed by a small company in Japan. At about the same time, InterMune, an American company, developed a competing drug. InterMune bought out the Japanese company and put the research of Pirfenidone "on the back burner" because it was finanacially beneficial to InterMune to try to get their drug approved. When their drug did not look promising they switched thier efforts to Pirfenidone. Hence, the long time delay.btw, thanks for the link o the two research papers.Stu IPF 8/06> >> > Is there anybody that is in the Pirfenidone experimental drug study or > > is in the process of qualifying for it ?> > > > Stu IPF 8/06> >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 29, 2006 Report Share Posted October 29, 2006 > > > > > > Is there anybody that is in the Pirfenidone experimental drug > study or > > > is in the process of qualifying for it ? > > > > > > Stu IPF 8/06 > > > > > >: My husband has a lift chair for his diabetic neuropathy. Medicare is difficult to deal with and will only pay for the cost of the lift mechanism. The doctor has to prescribe the chair, then the store where you buy the chair has to get the doctor to sign a certificate. Then the store sends all that to Medicare. We got his chair in July and we still do not have $$$ from Medicare. I'm not sure if the store is not sending the right paperwork or what. The catch is: the patient is not allowed to give the certificate to the doctor and the authorized store must send in the paperwork... but, first we had to pay for the chair!! I still don't know if Medicare will send us any reimbursement. I really wish I had just bought a lift chair at a furniture store and forgot about Medicare. It would have been cheaper in the long run. The chair we bought was about $1,200 and Medicare might pay up to $400 (80% of what the store says is the cost of the lift). Lazyboy makes a chair, but will not file Medicare. None of the " furniture stores " that carried the chair would file. We bought it from a health care supply store thinking Medicare would pay for it. I am recently diagnosed with IPF. You folks are giving me a lot of much needed info. I gotta quit smoking, having trouble with that.. only smoked 4 cigarettes today.. but I MUST quit 100%. Anyone have any suggestions? Gale17444 in Texas Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 30, 2006 Report Share Posted October 30, 2006 , please check out www.clinicaltrials.org i was not aware that trials cost anything out of pocket. i thought they looked for guinea pigs like us and the pharmacutical companies paid for it.........please look further into it before you go putting yourself in more debt that necessary. EG > > > > > > Is there anybody that is in the Pirfenidone experimental drug > study or > > > is in the process of qualifying for it ? > > > > > > Stu IPF 8/06 > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 30, 2006 Report Share Posted October 30, 2006 , The Pirfenidone study doesn't cost a dime. The drug company pays for everything. I'd suggset you contact InterMune and get a list of the qualifications for the study and find out the nearest clinic that is authorized to perform the study. Here is a link to a newsletter frrom the Irish Lung Fibrosis Association. The newsletter lists other drugs that might help with IPF and the like. - Stu IPF 8/06 Re: Pirfenidone study > > >> > > Is there anybody that is in the Pirfenidone experimental drug> study or> > > is in the process of qualifying for it ?> > >> > > Stu IPF 8/06> > >> >>:My husband has a lift chair for his diabetic neuropathy. Medicare isdifficult to deal with and will only pay for the cost of the liftmechanism. The doctor has to prescribe the chair, then the store whereyou buy the chair has to get the doctor to sign a certificate. Then thestore sends all that to Medicare. We got his chair in July and we stilldo not have $$$ from Medicare. I'm not sure if the store is not sendingthe right paperwork or what. The catch is: the patient is not allowedto give the certificate to the doctor and the authorized store must sendin the paperwork... but, first we had to pay for the chair!! I stilldon't know if Medicare will send us any reimbursement. I really wish Ihad just bought a lift chair at a furniture store and forgot aboutMedicare. It would have been cheaper in the long run. The chair webought was about $1,200 and Medicare might pay up to $400 (80% of whatthe store says is the cost of the lift). Lazyboy makes a chair, butwill not file Medicare. None of the "furniture stores" that carried thechair would file. We bought it from a health care supply store thinkingMedicare would pay for it.I am recently diagnosed with IPF. You folks are giving me a lot ofmuch needed info. I gotta quit smoking, having trouble with that.. onlysmoked 4 cigarettes today.. but I MUST quit 100%. Anyone have anysuggestions?Gale17444 in Texas Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 7, 2006 Report Share Posted November 7, 2006 Hi Stu, It turned out that I need to be off NAC for 28 days. The Pulm told me yesterday so I need to 'dry out' so I can have the tests run. It looks promising for me to get into the study. I'm hoping to get started in early December. My biopsy confirmed UIP IPF. Ken Baker UIP IPF 12/05 > > > > > > Is there anybody that is in the Pirfenidone experimental drug > study or > > > is in the process of qualifying for it ? > > > > > > Stu IPF 8/06 > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 7, 2006 Report Share Posted November 7, 2006 u did not just stop the prednisone i hope! that can be bad bad bad bad. EG -- In Breathe-Support , " ridgerunnernh " wrote: > > Hi Stu, > It turned out that I need to be off NAC for 28 days. The Pulm told me > yesterday so I need to 'dry out' so I can have the tests run. It > looks promising for me to get into the study. I'm hoping to get > started in early December. My biopsy confirmed UIP IPF. > > Ken Baker UIP IPF 12/05 > > > > > > > > > > Is there anybody that is in the Pirfenidone experimental drug > > study or > > > > is in the process of qualifying for it ? > > > > > > > > Stu IPF 8/06 > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 8, 2006 Report Share Posted November 8, 2006 Hi , I have not been on any prednisone so I don't have that problem but thanks for your concern. I have only been using NAC 600mg three times a day. The pirfenidone study requires me to have been off all IPF treatment for 28 days so my pulm told me to stop the NAC. It looks promising for me to get into the pirfenidone study as I'm in early stage of the disease and not on oxygen unless needed. My first diag was in Dec05 and disease progression has been minimal since then. Biopsy 10/06 confirmed the diagnosis. I still have some local chest pain from the VATS biopsy but the surgeon said that could continue for some time. Ken Baker UIP IPF 12/05 > > > > > > > > > > Is there anybody that is in the Pirfenidone experimental > drug > > > study or > > > > > is in the process of qualifying for it ? > > > > > > > > > > Stu IPF 8/06 > > > > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 8, 2006 Report Share Posted November 8, 2006 I was going to do the same study until I found they require a lung bio! That stopped that quick enough....for me anyway. I'm in mild stage also and Dr. advised against. This is just me though Ken! I'm sure your Dr. and you know best for you. God Bless. Sher ipf -5-06 Re: Pirfenidone study Hi ,I have not been on any prednisone so I don't have that problem butthanks for your concern. I have only been using NAC 600mg three timesa day. The pirfenidone study requires me to have been off all IPFtreatment for 28 days so my pulm told me to stop the NAC. It looks promising for me to get into the pirfenidone study as I'm inearly stage of the disease and not on oxygen unless needed. My firstdiag was in Dec05 and disease progression has been minimal since then.Biopsy 10/06 confirmed the diagnosis. I still have some local chestpain from the VATS biopsy but the surgeon said that could continue forsome time. Ken Baker UIP IPF 12/05> > > > >> > > > > Is there anybody that is in the Pirfenidone experimental > drug > > > study or > > > > > is in the process of qualifying for it ?> > > > > > > > > > Stu IPF 8/06> > > > >> > > >> > >> >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 8, 2006 Report Share Posted November 8, 2006 Hi You, Did you get your IM straightened out? I went to my pulm Dr today and She said just keep on doing what ever it is I'm doing..Well that would be nothing. I only take my synthroid, psycho. and ambian so I can get some sleep. She does want me to take NAC even though I don't have a cough. So I will, I am soooo bad with pills. If it's not going to make me better I just can't take them. So anyhow I'm good until I see the transplant Doc. the 7th of Dec. How are you feeling? I know all the rain has your bones in a thither. Are you high and dry? Love and Prayers, Peggy 9/04 ipf I was going to do the same study until I found they require a lung bio! That stopped that quick enough....for me anyway. I'm in mild stage also and Dr. advised against. This is just me though Ken! I'm sure your Dr. and you know best for you. God Bless. Sher ipf -5-06 Re: Pirfenidone study Hi , I have not been on any prednisone so I don't have that problem but thanks for your concern. I have only been using NAC 600mg three times a day. The pirfenidone study requires me to have been off all IPF treatment for 28 days so my pulm told me to stop the NAC. It looks promising for me to get into the pirfenidone study as I'm in early stage of the disease and not on oxygen unless needed. My first diag was in Dec05 and disease progression has been minimal since then. Biopsy 10/06 confirmed the diagnosis. I still have some local chest pain from the VATS biopsy but the surgeon said that could continue for some time. Ken Baker UIP IPF 12/05 > > > > > > > > > > Is there anybody that is in the Pirfenidone experimental > drug > > > study or > > > > > is in the process of qualifying for it ? > > > > > > > > > > Stu IPF 8/06 > > > > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 9, 2006 Report Share Posted November 9, 2006 Yes, I think the im is ok...i never see you on but my im name has been changed to sherbauman. I sent you notice, did you get it? In fact, i'm on right now. Reading the posts....88 of them! I went to Lysa's overnight and now my eyeballs are on my cheeks, catching up. Actually, I'm feeling better. I think it's the Cymbalta Dr. changed me to. I feel more energetic and I'm doing more. I feel badly for Ginger! It's so hard to accept when she seems to go 'downhill' even for a moment. Love, Sher Re: Pirfenidone studyHi ,I have not been on any prednisone so I don't have that problem butthanks for your concern. I have only been using NAC 600mg three timesa day. The pirfenidone study requires me to have been off all IPFtreatment for 28 days so my pulm told me to stop the NAC. It looks promising for me to get into the pirfenidone study as I'm inearly stage of the disease and not on oxygen unless needed. My firstdiag was in Dec05 and disease progression has been minimal since then.Biopsy 10/06 confirmed the diagnosis. I still have some local chestpain from the VATS biopsy but the surgeon said that could continue forsome time. Ken Baker UIP IPF 12/05> > > > >> > > > > Is there anybody that is in the Pirfenidone experimental > drug > > > study or > > > > > is in the process of qualifying for it ?> > > > > > > > > > Stu IPF 8/06> > > > >> > > >> > >> >> Quote Link to comment Share on other sites More sharing options...
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