Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316414
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-06
Brief Title:
Omalizumab in Severe Asthmatics With Food Allergy
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Bambino Gesù Hospital and Research Institute
Study Overview
Official Title:
Effects of Omalizumab on Food Allergy in Children With Severe Asthma A Real Life Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSAFA
Brief Summary:
A prospective assessment of the impact of Omalizumab in terms of efficacy safety and quality of life FA-QoL in patients with moderatesevere asthma and history of anaphylaxis to peanut tree nuts fish egg milk andor wheat Evaluation of the trend of total and specific IgE during Omalizumab treatment
Detailed Description:
Children 6-18 yrs with severe asthma eligible for treatment with Omalizumab and reporting food anaphylaxis to be assessed for their concomitant food allergy
At T0
oral food challenges OFCs to establish the threshold of reaction to the culprit foods
number and severity of food-allergic reactions in the previous 12 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T1 - four months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T2 - eight months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T1 - twelve months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T0
oral food challenges OFCs to establish the threshold of reaction to the culprit foods
number and severity of food-allergic reactions in the previous 12 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T1 - four months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T2 - eight months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
At T1 - twelve months after starting Omalizumab treatment
OFCs to the previously positive foods with evaluation of the threshold of reaction
number and severity of food-allergic reactions in the previous 4 months recorded
Asthma Control Test
Food Allergy-Quality of Life FA-QoL questionnaire
total IgE
specific IgE for the culprit foods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None