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xolair

5 replies [Last post]
By pamom on Tue, 03-30-04, 15:33

Hi everyone!

It has been awhile, we moved in January from Indiana to Nebraska. The new school is great!

I just read an article in this morning's paper on Xolair. I knew it has come out and it is an anti IgE drug. I have also read in a separate article that although it is being used to treat severe asthma, it may really help severe allergy patients, ie peanut allergy. It is expensive 5-10,000 a year, but insurance companies are paying it because hospitalizations are more expensive.

Does anyone have any information or are any of your allergist willing to prescribe this shot? I know right now it is being used for 12 and over, but they are now testing it on under 12 candidates. Tanox is also an anti igE drug, has anyone heard what the status of this is?

Let me know. My 10 and 8 year old are very severe and we would love some hope.

Thanks

Pamom

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By NOPEANUTSALLOWED on Sat, 04-03-04, 15:39

Hello everyone,

I am assuming none of you have read anything, but I am raising this topic again.

Let me know!

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By pgrubbs on Sat, 04-03-04, 20:51

Our old allergist was very supportive, had prescribed it to others, and all insurance was paying. Our Dd is too young, but she thought it was an option for her when she gets older.

Paula

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By ajinnj on Sun, 04-04-04, 04:44

There have been MANY threads on this topic. Here is one link to the most recent thread:
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html[/url]
You can also do a search to see all the related threads.

Allison

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By Jana R on Thu, 07-01-04, 14:40

Here's a link listing research locations:
[url="http://www.clinicaltrials.gov/ct/gui/show/NCT00079937?order=1"]http://www.clinicaltrials.gov/ct/gui/show/NCT00079937?order=1[/url]
[i][b]The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma[/b]

This study is currently recruiting patients.

Sponsored by

Novartis Pharmaceuticals
Purpose

This study will look at data collected over 1 year to determine the effectiveness of omalizumab (Xolair) in controlling moderate-to-severe allergic asthma in children 6 to 12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and other clinical and laboratory measures.

Condition Treatment or Intervention Phase
Asthma
Drug: Omalizumab
Phase III

MedlinePlus related topics: Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 1-year, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Efficacy, Safety, and PK/PD of Omalizumab in Children (6 - <12 years) with Moderate-Severe, Persistent, Inadequately Controlled Allergic Asthma

Further Study Details:

This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Eligibility

Ages Eligible for Study: 6 Years - 12 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

outpatient who agrees to written informed consent
male or female of any race aged 6 to 12 years old
body weight greater than or equal to 20 kg (~44 lbs) and less than or equal to 150 kg (~330 lbs)
total serum IgE level equal to or greater than 30 to equal to or less than 1300 IU
diagnosis of allergic asthma equal to or greater than 1 year
positive skin prick test to at least one perennial allergen
equal to or greater than 12% increase in FEV1 within 30 min of taking salbutamol
past medical history of exacerbations
evidence of inadequate asthma symptom control
inhaled corticosteroid dose equivalent to fluticasone DPI equal to or greater than 200 mcg/day
AND

2 exacerbations in the previous 12 months requiring treatment with oral or IV corticosteroids and/or a doubling of the maintenance inhaled corticosteroid dose for at least 3 days
OR

3 exacerbations in the previous 24 months; 1 of which occurred in the previous 12 months (same treatment as above)
OR

hospitalization (including ICU) or received ER treatment (including urgent care centers) in the past 12 months for an asthma exacerbation, as defined by the GINA 2002 guidelines for a severe exacerbation
Exclusion Criteria:

pregnant or breast-feeding
nonadherence to protocol medicaton washouts
treatment with unacceptable concomitant medications
current or past clinically significant uncontrolled systemic disease
current, past, or potential cancers
platelet levels equal to or less than 130 x 109/L at Visit 1
previous treatment with Xolair
unable either alone or with their caretaker to perform spirometry, peak flow measurements or completion of the diary card
history of food or drug-related severe anaphylactoid or anaphylactic reaction(s)
history of allergy to antibiotics
Other protocol-defined exclusion criteria may apply.

Expected Total Enrollment: 570[/i]

------------------
Jana

[url="http://www.seattlefoodallergy.org"]www.seattlefoodallergy.org[/url]

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By pennykandy on Sat, 07-03-04, 01:54

My daughter's Allergist made it sound like insurance companies were not covering this in general for kids. I looked at the link for the trial mentioned above, and my daughter's pulmonologist is listed...then I read the exclusion factors, you cannot have had a previouse anaphylaxis.

The allergist thinks this would be a great drug for her, he thinks allergy shots are too risky AND we have not been able to control her asthma despite being on the max dose of Advair, double dose of Zyrtec, and Max dose of Singulair she still has to go on oral steroids several times a year.

Sorry didn't mean to turn this into a book.

Penny

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