Trial Outcomes & Findings for Immune Dysfunction in Allergic Asthma (NCT NCT00189228)

Results Overview

Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. 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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2019-09-27

Participant Flow

Recruitment from the University community

No events prior to the study

Participant milestones

Participant milestones
Measure	Xolair This is not a drug study examining differences of therapeutic outcomes. This is an open label, non randomized single dose level study in which patients will be treated for 85 days with rhuMAB-E25 (Xolair) and followed for a total of 300 days. The dose of Xolair is determined by the patient's total serum IgE and body weight and is administered subcutaneously every 2 or 4 weeks. Outcome is serum anti-KLH antibody (immunoglobulin classes).
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Dysfunction in Allergic Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xolair n=18 Participants This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Anti-KLH antibody levels of the groups (asthmatics treated with Xolair and placebo) were compared. Both parametric and non parametric statistical techniques were used. There were no differences between the groups.

Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. 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

Outcome measures

Outcome measures
Measure	Xolair n=18 Participants This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
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	18 Units of anti-KLH antibody Standard Error 2

Adverse Events

Xolair

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Schuyler

University of New Mexico Health Sciences Center

Phone: 5059254197

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place