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Monoclonal Antibodies

xolair for 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 below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 • NCT00624832

22%

Headache

17%

Nasopharyngitis

11%

Vertigo

Toothache

Injection site swelling

Papilloma

Eye irritation

Eye pruritus

Wound complication

Infusion site erythema

Conjunctivitis

Herpes virus infection

Dyspnoea

Hypertension

Viral infection

Cough

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met