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Monoclonal Antibodies
Immune Dysfunction in Allergic Asthma
N/A
Waitlist Available
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mild asthma, adults -
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.
Eligible Conditions
- Asthma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution
Side effects data
From 2009 Phase 4 trial • 60 Patients • NCT0062483222%
Headache
17%
Nasopharyngitis
11%
Vertigo
6%
Toothache
6%
Injection site swelling
6%
Papilloma
6%
Eye irritation
6%
Eye pruritus
6%
Wound complication
6%
Infusion site erythema
6%
Conjunctivitis
6%
Herpes virus infection
6%
Dyspnoea
6%
Hypertension
6%
Viral infection
6%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Xolair (IgE= 30- 300 IU/mL)
Xolair (IgE= 700- 2000 IU/mL)
Xolair (IgE= 301- 699 IU/mL)
Placebo Comparator
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: xolairExperimental Treatment1 Intervention
This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omalizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
388 Previous Clinical Trials
3,526,585 Total Patients Enrolled
2 Trials studying Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,811 Total Patients Enrolled
282 Trials studying Asthma
114,405 Patients Enrolled for Asthma
Mark Schuyler, MDStudy DirectorUNM HSC