Immune Dysfunction in Allergic Asthma

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT00189228
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Xolair	N/A

Detailed Description

Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Not a Drug Trial. We Are Using Anti-IgE to Examine the Role of Pulmonary Mast Cells in Asthma
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: xolair 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.	Drug: Xolair; Patients are administered Xolair

Outcome Measures

Primary Outcome Measures

1. 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 [6 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Mild asthma, adults -

Exclusion Criteria:

children. on inhaled or systemic steroids

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNM HSC	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

• University of New Mexico
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Director: Mark Schuyler, MD, UNM HSC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Schuyler, Professor of Medicine, University of New Mexico
• ClinicalTrials.gov Identifier: NCT00189228
• Other Study ID Numbers: UNMSCOR; R01HL044253; NCT00201097
• First Posted: Sep 16, 2005
• Last Update Posted: Sep 27, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Asthma; Omalizumab

Study Results

Participant Flow

Recruitment Details	Recruitment from the University community
Pre-assignment Detail	No events prior to the study

Arm/Group Title	Xolair
Arm/Group Description	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).
Period Title: Overall Study
STARTED	18
COMPLETED	18
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Xolair
Arm/Group Description	This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
Overall Participants	18
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	10 55.6%
Male	8 44.4%
Region of Enrollment (participants) [Number]
United States	18 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Xolair
Arm/Group Description	This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
Measure Participants	18
Mean (Standard Error) [Units of anti-KLH antibody]	18 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xolair
	Comments	This is not a drug study.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Xolair
Arm/Group Description	This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
All Cause Mortality
	Xolair
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Xolair
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Xolair
	Affected / at Risk (%)	# Events
Total	0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.