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I wrote this last post at 1:30 in the morning during a bout with insomnia, so I guess my thinking wasn’t clear (that’s what I’ll blame it on anyway!) I agree with aboveallislove, FEV1 shouldn’t affect labeling for Orcambi. In prior Vertex studies for Kalydeco, even though there were restrictions...

I'm not sure exactly what the Orkambi labeling will include. I just know past studies only included those patients with FEV1 of 40% or higher. There is a Vertex study currently enrolling for ddf508 with FEV1 under 40%: https://clinicaltrials.gov/ct2/show/NCT02390219?term=vx+809&rank=11...

Agreed. Statements were very powerful, accurate, and effective. Here is an example: Masters, who testified before the advisory panel, said the drug has dramatically changed his life, allowing him to gain weight and improving his lung function enough so he can run 5 kilometer road races.“For...

Aboveallislove Speaking of advocates, I just wanted to thank you for being such an advocate for the CF community on this forum. You do a wonderful job not just keeping us informed, but also offering support. You started the thread alerting us about this advisory committee and encouraging us to...

I received some more information re: 661 study (108) for residual function https://clinicaltrials.gov/ct2/show/NCT02392234 I spoke with the study nurse coordinator from Tucson AZ CF center (pediatric and adult). She was very helpful and said that although she can’t share the mutations that are...

This is such great news! It made my day! As your bio states, you certainly are "saving your life one day at a time". Great job advocating for yourself. I can't wait hear about your progress once you start. Please keep us updated.

I went through something very similar as well. My low grade fevers, joint pain, fatigue started to be a persistent, almost daily, issue for me a couple of years ago. My fevers usually occurred around the same time of day (early afternoon) and I would get the chills. They would rarely go above...

Sorry, you lost me on the 661 study. What arm are you talking about? Is it a current study or one that is expected soon? To answer your other question, I’ll probably just stay with the Kalydeco. I still have this fear that my insurance covered this inadvertently since there were no questions...

Thanks aboveallislove, I am one of the lucky ones that is receiving it off-label. Kalydeco alone has done wonders. I wasn't trying to get into the 661 study at this time. I'm just so upset for the other 163 people that share my mutation because once the study is done and it is officially...

Just talked to another study nurse. Even though she has the list, she can’t give it to me. What I did find out is that they are going by genotype only, not phenotype (pancreatic sufficiency). She did inform me that my mutation is not listed (r334w) I’m a class IV conductance mutation so there...

I found out some information, but still don't know how "residual function" will be defined. According to one of the research nurses that is involved with this study, it will be difficult to get into this particular study if your CF center is not participating because the enrollment is limited...

Autumn, yes, you have it right. I just looked it up on the clinicaltrials.gov site. It is listed as enrolling. It’s very strange that the representative at Vertex didn’t know this. He even asked me for the clinical trial number and looked it up in their system. This was on Friday. The...

Just wanted to give an update. Unfortunately I didn’t get very far. I called both Vertex and CFF and neither were able to provide any more information regarding the inclusion criteria for the VX-661 study for residual function mutations. The person I spoke with at Vertex said he thought the...

I just wanted to let you know that I didn’t find out any further information about how Vertex is defining residual function for this study. The research nurse at my clinic wasn’t able to provide an answer. I’m hoping that the inclusion criteria is broad and includes all Class IV and V...

Hi Autumn Sounds like you never had any luck with convincing your new doctor to order Kalydeco? I'm sorry to hear this. But it would be great if you could get in this study. I'm not from Texas but this is some contact info. I gathered from the TX care centers participating in the study...

Hi Autumn Sounds like you never had any luck with convincing your new doctor to order Kalydeco? I'm sorry to hear this. But it would be great if you could get in this study. I'm not from Texas but this is some contact info. I gathered from the TX care centers participating in the study...

Are you pancreatic sufficient or was your sweat test diagnostic of CF but on the lower side of abnormal (I think less than 80 was the value they used in the inclusion criteria for Denver trial for residual function but I’m not sure) If so, than you would be considered to have some residual...

I'm not sure but it is my understanding that e-flow/e-rapid is the general name for the system (the purple/blue round main compressor). The metal disk (not the plastic handset) is specific to certain medications. I use a certain metal head with "Altera" printed on it for Cayston. I use another...

Glad you found this forum foxalive. According to the CF registry, there are 164 people in the world with our mutation. I would have never thought I would be able to be touch with someone that shares my mutation, let alone someone from Russia! Technology is amazing. I sent you a PM.

I don’t have any experience with Methotrexate, but I have had problems with severe inflammation. I'm guessing you are already on xopenex or albuterol and an inhaled steroid like advair or symbacort? At one point I tried qvar (steroid) in addition to advair. Beclomethosone is the nebulized...