Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078195
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2004-02-19
Brief Title:
Omalizumab Xolair and Allergy Shots For the Treatment of Seasonal Allergies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab an Anti-IgE Monoclonal Antibody ITN019AD
Status:
COMPLETED
Status Verified Date:
2016-10
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:
A series of allergy shots may reduce symptoms of seasonal ragweed allergies This study will determine whether taking a drug called omalizumab also known as Xolair before getting the allergy shots is more effective than allergy shots alone or other treatments such as prescription antihistamines
Detailed Description:
Allergic rhinitis affects 20 to 40 million Americans annually Allergy symptoms which can range from mild to seriously debilitating may affect quality of life Left untreated allergic rhinitis can exacerbate or trigger more serious conditions such as asthma and sinus inflammation
Individuals with allergies react to harmless particles such as dust or pollen Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response The immune response results in harmful inflammation of healthy tissues In ragweed allergy inflammation occurs in the airways and causes familiar allergy symptoms like sneezing coughing and general discomfort
Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies The blocking effect of omalizumab is temporary but giving the drug to people before their regular allergy shots may make the shots more effective
Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots given over 12 weeks The participants will return for follow-up for up to one year and they may have as many as 27 study visits
Individuals with allergies react to harmless particles such as dust or pollen Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response The immune response results in harmful inflammation of healthy tissues In ragweed allergy inflammation occurs in the airways and causes familiar allergy symptoms like sneezing coughing and general discomfort
Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies The blocking effect of omalizumab is temporary but giving the drug to people before their regular allergy shots may make the shots more effective
Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots given over 12 weeks The participants will return for follow-up for up to one year and they may have as many as 27 study visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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