Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437171
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-17
Brief Title:
FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA
Sponsor:
AAADRS Clinical Research Center
Organization:
AAADRS Clinical Research Center
Study Overview
Official Title:
The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This is a Phase IV open-label single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA
Detailed Description:
This is a Phase IV open-label single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA Twenty 20 participants will be enrolled over a 9-month enrollment period from an allergy and asthma medical specialty clinic Should the participant meet all eligibility criteria then following the Screening Period the participant will be dosed with OMA and asked to continue to follow their food avoidance regimen
Participants will return to the clinic every two weeks for 16-weeks and then every 2 or 4-weeks depending on dosing for the remaining 36-weeks for a total of 52-weeks Primary endpoint analyses will occur at Week 16 and Week 52
Description of XOLAIR treatment schedule
Omalizumab will be dosed according to the OUtMATCH Study dosing Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction site personnel must be able to detect and treat such reactions Patients with severe hypersensitivity reactions eg stridor angioedema life-threatening change in vital signs must be withdrawn from study treatment
All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor
Participants will return to the clinic every two weeks for 16-weeks and then every 2 or 4-weeks depending on dosing for the remaining 36-weeks for a total of 52-weeks Primary endpoint analyses will occur at Week 16 and Week 52
Description of XOLAIR treatment schedule
Omalizumab will be dosed according to the OUtMATCH Study dosing Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction site personnel must be able to detect and treat such reactions Patients with severe hypersensitivity reactions eg stridor angioedema life-threatening change in vital signs must be withdrawn from study treatment
All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None