DS went to the doc's today. She offered to have him involved in the study they are currently conducting for kids 6-11 who have severe asthma. They are also trying to get FDA approval to trial Xolair in children with PA.
My question...does anyone know any reasons NOT to seriously look at joining this study? Thanks for your input. Kristi
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Thanks for the heads-up e-mail [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]
Is this a trial for asthma kids or PA kids? I thought Xolair was already approved for kids under 12 with severe asthma. DS is only 7 and our insurance has approved treatment with Xolair - thought they wouldn't do that if it was considered "experimental"?
I wonder if the Xolair people would be interested in tracking my son's allergic reactions or whatever even without him specifically being in the trial (since his pulmo doesn't want to run the risk of getting the placebo). The nurse who called with info for us did ask very specific questions about allergies but not PA. She seemed to be trying to determine if DS was atopic. She didn't seem to be very on the ball though - she insisted on explaining to me what a subcutaneous (sp?) injection was even though I told her that I give DS sub-q injections every night (grrr) - so who knows if DS's allergy info will get to anyone who might actually be interested in it...
Keep us posted...
Rebekah
Bumping. I want to make this decision soon. To clarify what rebekahc asked...
This study is to determine the safety and effectiveness of Xolair for use in children with severe asthma ages 6-11. (I think you are lucky the insurance is paying for it.) This has been approved for children ages 12+.
He has a 2/3 chance of getting Xolair rather than the placebo. I am thinking this is worth it. Your thoughts?
The same organization is still waiting for FDA permission to try Xolair on children under 18 with regards to PA.
I'll keep you posted. Kristi
Kristi ~
DS had his first injections of Xolair today. Although I'm excited for the possible results of these injections it was not a pleasant experience for him poor guy! [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]
He is on the once per 4 week dosing schedule and as a result he had to have two HUGE injections. A total of almost 3 cc (which is a heck of a lot!) The Xolair is very thick and so they have to use a very large needle for the injection (23 gauge or larger - picture a needle used to draw blood). They also have to inject it very slowly because of the thickness. DS was a real trooper though and only shed a few tears - no screaming.
The pulmonologist did say that since I am willing and qualified to give DS injections and also equipped to recognize and treat anaphylaxis or other allergic reactions that after the first 3 or 4 doses he will probably let me administer the injections to DS at home. I will probably see if we could use smaller more frequent doses instead of the huge dose (there is a 2 week dosing schedule, too).
Hopefully by December the anti-IgE will be in full effect and we can get him a puppy for Christmas! Lord knows he deserves it!!
Rebekah
P.S. My cost is $25/month for the Xolair and $15 for the doctor's office. Not too bad for such a wonder drug!
Rebekah,skanb
Please keep us posted.
Good Luck!!!
Love this site
Synthia
Rebekah, Thanks for the update. Sounds like your ds was a real trooper. I'm hoping it won't be too traumatic for my ds. He's been getting allergy shots for two years+. I know that the needle is bigger, but I hope these have prepared him for this.
We've decided to go ahead with the trial. He goes in Monday for his initial intake and then will be monitored for nine weeks before they start the injections. From everything I've heard, if I'm observant I will be able to tell if he is getting the Xolair or the placebo. I will keep you posted.
Thanks again for the update. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Kristi
GENENTECH Announces Second Quarter 2004 Results
Scroll down to where it says immunology and specialty biotherapeutics.
Basically, it says that the first patient was enrolled for Phase II trials using Xolair for peanut allergy. There will be 150 patients.
[url="http://www.prnewswire.com/cgi-bin/stories.pl?AC"]http://www.prnewswire.com/cgi-bin/stories.pl?AC[/url]
CT=SVBIZINK3.story&STORY=/www/story/07-07-2004/0002206308&EDATE=WED+Jul+07+2004,+04:29+PM
Another item says the trial will last 38 weeks.
[url="http://www.thestreet.com/markets/stocksinmotion/10169948.html"]http://www.thestreet.com/markets/stocksinmotion/10169948.html[/url]
Any ideas on how long before they might see the effects of this study and if the trials go well, when do they think it will come to market for the general public?
I am curious to see if anyone knows of a patient as young as 4 to take xolair. Aidan is being recommended for it & he turns 4 in Jan. We are exhausting our options with asthma meds & this is the next "step" I am trying to read up on this miracle drug, but have not seen how young they have gone. If anyone has any info I would appreciate it.
Thanks!!!
Mandi
Mandi,
Haven't heard how young a child they are using this drug for. Sorry. I wish I had more answers for you.
It turns out that ds is not eligible for the drug trial, as his scores are too high. They drew blood in March 2800+, June 1600, and October 2100+. This is in spite of his allergy shots for more than two years! He gets them for cats, dogs, dustmites, grass, weeds, etc. We go in next week to talk with his physician and see if we're going to do it with the insurance company paying instead of through the study.
Good luck to all. Kristi
Thanks Kristi, I am still seeking info if anyone has ??anything?? He is a big boy and on adult doses for his asthma. I sometimes say he is allergic to air. Not funny, but sometimes it does fill like that. So I appreciate any info.
Mandi
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