To those on kalydeco---Lauren (your thoughts, please)

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Allansarmy

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>LouLou</b></i>On that note, if anyone ever works on trying to change the FDA's requirement for CFers to NOT have to do placebo in studies I would back you and go to DC for such a effort!</end quote>
I didn't want to include all of your text here, just the part I wanted to respond to. So basically on this study they had you take the Kalydeco and then stop cold turkey and give you placebo. During the placebo were you allowed to take any other drugs (i.e. Pulmozyme, Tobi, Albuterol) type of drugs? - No need to respond soon, I was just curious because it sounds likea brutal trial.
I work in an ENT office and my doc that I work for also has a side research business that I occasionally help out with. Nothing as big as what you are on, but I was just curious how the coordinators thought this would be a good idea to stop cold turkey etc.
 
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Allansarmy

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>LouLou</b></i>On that note, if anyone ever works on trying to change the FDA's requirement for CFers to NOT have to do placebo in studies I would back you and go to DC for such a effort!</end quote>
I didn't want to include all of your text here, just the part I wanted to respond to. So basically on this study they had you take the Kalydeco and then stop cold turkey and give you placebo. During the placebo were you allowed to take any other drugs (i.e. Pulmozyme, Tobi, Albuterol) type of drugs? - No need to respond soon, I was just curious because it sounds likea brutal trial.
I work in an ENT office and my doc that I work for also has a side research business that I occasionally help out with. Nothing as big as what you are on, but I was just curious how the coordinators thought this would be a good idea to stop cold turkey etc.
 

cdale613

New member
Hi All,

I have been on Kalydeco for two weeks through the last VX-770 research effort tracking long term use for a year at UVA. I am continuing my full routine of meds for the time being.

The first change I notices were my nasal passages - within about 4 hours. They feel like I just did a sinus rinse.

Chest wise, I noticed a difference in 3 days. I feel MUCH less tight or inflamed. I don't hear crackles when I lie down to go to sleep, etc. It basically feels like I'm in the middle of a course of IVs without the nasty side effects...
My level of congestion/mucous production has lessened some, but I continue to be quite productive. However, my color has been all over the place - some days very light greenish yellow, other days gross greenish brown. I have been getting up a few plugs, though nothing black, etc.

After five days, my FEV1 was up 4%, to 84% of normal.

The biggest noticeable change so far has been in my digestive tract - My bowels feel great, using the bathroom less frequently, and everything is sinking... I've also gained a couple pounds, but have been changing my diet to not gain weight. My BMI is 22, and I am happy with it where it is, and have no desire to gain.

Emotionally it has been quite a roller coaster - I feel like I have been told I will live, and it is incredible. A huge weight feels like it is lifting off of me. I am aware of how incredibly lucky I am, and its a lot to take in. I feel like I have flipped a hundred coins, and every one has come up heads. My wife and I talked about kids for the first time in four years of marriage last week. Its amazing to see her belief that something like this would happen be validated. I also feel guilty to be among the so few benefiting from this.

However, I also feel like I worked incredibly hard to put myself in a position to benefit from a drug like this at age 31, and I have to pinch myself - I can't believe it is here. If I had anything to say to everyone not immediately impacted by Kalydeco, it is this: Keep doing the hard work. It isn't easy, but its worth it, and it will pay off for all of us.

Chris
 

cdale613

New member
Hi All,

I have been on Kalydeco for two weeks through the last VX-770 research effort tracking long term use for a year at UVA. I am continuing my full routine of meds for the time being.

The first change I notices were my nasal passages - within about 4 hours. They feel like I just did a sinus rinse.

Chest wise, I noticed a difference in 3 days. I feel MUCH less tight or inflamed. I don't hear crackles when I lie down to go to sleep, etc. It basically feels like I'm in the middle of a course of IVs without the nasty side effects...
My level of congestion/mucous production has lessened some, but I continue to be quite productive. However, my color has been all over the place - some days very light greenish yellow, other days gross greenish brown. I have been getting up a few plugs, though nothing black, etc.

After five days, my FEV1 was up 4%, to 84% of normal.

The biggest noticeable change so far has been in my digestive tract - My bowels feel great, using the bathroom less frequently, and everything is sinking... I've also gained a couple pounds, but have been changing my diet to not gain weight. My BMI is 22, and I am happy with it where it is, and have no desire to gain.

Emotionally it has been quite a roller coaster - I feel like I have been told I will live, and it is incredible. A huge weight feels like it is lifting off of me. I am aware of how incredibly lucky I am, and its a lot to take in. I feel like I have flipped a hundred coins, and every one has come up heads. My wife and I talked about kids for the first time in four years of marriage last week. Its amazing to see her belief that something like this would happen be validated. I also feel guilty to be among the so few benefiting from this.

However, I also feel like I worked incredibly hard to put myself in a position to benefit from a drug like this at age 31, and I have to pinch myself - I can't believe it is here. If I had anything to say to everyone not immediately impacted by Kalydeco, it is this: Keep doing the hard work. It isn't easy, but its worth it, and it will pay off for all of us.

Chris
 

dramamama

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>cdale613</b></i> Hi All, I have been on Kalydeco for two weeks through the last VX-770 research effort tracking long term use for a year at UVA. I am continuing my full routine of meds for the time being. The first change I notices were my nasal passages - within about 4 hours. They feel like I just did a sinus rinse. Chest wise, I noticed a difference in 3 days. I feel MUCH less tight or inflamed. I don't hear crackles when I lie down to go to sleep, etc. It basically feels like I'm in the middle of a course of IVs without the nasty side effects... My level of congestion/mucous production has lessened some, but I continue to be quite productive. However, my color has been all over the place - some days very light greenish yellow, other days gross greenish brown. I have been getting up a few plugs, though nothing black, etc. After five days, my FEV1 was up 4%, to 84% of normal. The biggest noticeable change so far has been in my digestive tract - My bowels feel great, using the bathroom less frequently, and everything is sinking... I've also gained a couple pounds, but have been changing my diet to not gain weight. My BMI is 22, and I am happy with it where it is, and have no desire to gain. Emotionally it has been quite a roller coaster - I feel like I have been told I will live, and it is incredible. A huge weight feels like it is lifting off of me. I am aware of how incredibly lucky I am, and its a lot to take in. I feel like I have flipped a hundred coins, and every one has come up heads. My wife and I talked about kids for the first time in four years of marriage last week. Its amazing to see her belief that something like this would happen be validated. I also feel guilty to be among the so few benefiting from this. However, I also feel like I worked incredibly hard to put myself in a position to benefit from a drug like this at age 31, and I have to pinch myself - I can't believe it is here. If I had anything to say to everyone not immediately impacted by Kalydeco, it is this: Keep doing the hard work. It isn't easy, but its worth it, and it will pay off for all of us. Chris</end quote>

<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Chris~
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">This is AWESOME!!!!! I am so excited for you and your family. You did hit the CF lotto. I think you are so wise to encourage all of us to work hard and take care of ourselves. I never thought I would see this day!! Praise GOD!
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">I am VERY intrigued by what you are saying as far as the nasal passages the first day. I know someone who felt the EXACT same way. Like moisture, I think.
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Question for you. Before the Kalydeco, were you a productive cougher or more tight and/or inflamed?
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">So, so happy for you. Thank you for sharing with us what it is like.
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Mandy
 

dramamama

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>cdale613</b></i> Hi All, I have been on Kalydeco for two weeks through the last VX-770 research effort tracking long term use for a year at UVA. I am continuing my full routine of meds for the time being. The first change I notices were my nasal passages - within about 4 hours. They feel like I just did a sinus rinse. Chest wise, I noticed a difference in 3 days. I feel MUCH less tight or inflamed. I don't hear crackles when I lie down to go to sleep, etc. It basically feels like I'm in the middle of a course of IVs without the nasty side effects... My level of congestion/mucous production has lessened some, but I continue to be quite productive. However, my color has been all over the place - some days very light greenish yellow, other days gross greenish brown. I have been getting up a few plugs, though nothing black, etc. After five days, my FEV1 was up 4%, to 84% of normal. The biggest noticeable change so far has been in my digestive tract - My bowels feel great, using the bathroom less frequently, and everything is sinking... I've also gained a couple pounds, but have been changing my diet to not gain weight. My BMI is 22, and I am happy with it where it is, and have no desire to gain. Emotionally it has been quite a roller coaster - I feel like I have been told I will live, and it is incredible. A huge weight feels like it is lifting off of me. I am aware of how incredibly lucky I am, and its a lot to take in. I feel like I have flipped a hundred coins, and every one has come up heads. My wife and I talked about kids for the first time in four years of marriage last week. Its amazing to see her belief that something like this would happen be validated. I also feel guilty to be among the so few benefiting from this. However, I also feel like I worked incredibly hard to put myself in a position to benefit from a drug like this at age 31, and I have to pinch myself - I can't believe it is here. If I had anything to say to everyone not immediately impacted by Kalydeco, it is this: Keep doing the hard work. It isn't easy, but its worth it, and it will pay off for all of us. Chris</end quote>

<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Chris~
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">This is AWESOME!!!!! I am so excited for you and your family. You did hit the CF lotto. I think you are so wise to encourage all of us to work hard and take care of ourselves. I never thought I would see this day!! Praise GOD!
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">I am VERY intrigued by what you are saying as far as the nasal passages the first day. I know someone who felt the EXACT same way. Like moisture, I think.
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Question for you. Before the Kalydeco, were you a productive cougher or more tight and/or inflamed?
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">So, so happy for you. Thank you for sharing with us what it is like.
<span style="font-size: small; font-family: 'comic sans ms', sans-serif;">Mandy
 

cdale613

New member
Thanks Mandy, It is incredible.

Before starting Kalydeco, I was (and still am) a very productive cougher. By comparison, any chest tightness/inflammation was secondary. On the drug, I am still productive throughout the day, but it feels like I just took my albuterol puffer.

C
 

cdale613

New member
Thanks Mandy, It is incredible.

Before starting Kalydeco, I was (and still am) a very productive cougher. By comparison, any chest tightness/inflammation was secondary. On the drug, I am still productive throughout the day, but it feels like I just took my albuterol puffer.

C
 
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ElenaFalcon

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>LouLou</b></i> Now I still have the need for inhaled antibiotics and have come to the conclusion that I will be disabled for the rest of my life (as long as I have these lungs) because of bronchiactisis (lung damage). </end quote>
Hope your lungs will benefit from 809/661 in addition to Kaly without lung tx because of lungs self-cleaning.Keep working, don't stop. Did you try to get into 809 trial?
 
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ElenaFalcon

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>LouLou</b></i> Now I still have the need for inhaled antibiotics and have come to the conclusion that I will be disabled for the rest of my life (as long as I have these lungs) because of bronchiactisis (lung damage). </end quote>
Hope your lungs will benefit from 809/661 in addition to Kaly without lung tx because of lungs self-cleaning.Keep working, don't stop. Did you try to get into 809 trial?
 

saveferris2009

New member
This is a great question. I have a feeling Kalydeco can't re-generate beta cells in the pancreas. But I would imagine some inflammation would decrease .....
 

saveferris2009

New member
This is a great question. I have a feeling Kalydeco can't re-generate beta cells in the pancreas. But I would imagine some inflammation would decrease .....
 

fhayden

New member
I actually have CFRD since 2005 and I'd love nothing more then to take a pill and watch it go far far away <img src="i/expressions/face-icon-small-smile.gif" border="0">
Frank
 

fhayden

New member
I actually have CFRD since 2005 and I'd love nothing more then to take a pill and watch it go far far away <img src="i/expressions/face-icon-small-smile.gif" border="0">
Frank
 

Incomudrox

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i> This is a great question. I have a feeling Kalydeco can't re-generate beta cells in the pancreas. But I would imagine some inflammation would decrease .....</end quote>

Kalydeco may not be able to but a lot of research in Germany and other sources says R-ALA and ALA can.
 

Incomudrox

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i> This is a great question. I have a feeling Kalydeco can't re-generate beta cells in the pancreas. But I would imagine some inflammation would decrease .....</end quote>

Kalydeco may not be able to but a lot of research in Germany and other sources says R-ALA and ALA can.
 

JoAnn

New member
For those of you taking Kalyceco - Do you take it with a fatty food like the directions say? Also do you take it the same times every day or is there wiggle room on the weekends to shift it a couple hours?
 

JoAnn

New member
For those of you taking Kalyceco - Do you take it with a fatty food like the directions say? Also do you take it the same times every day or is there wiggle room on the weekends to shift it a couple hours?
 
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