NCT00367016

Brief Summary

The purpose of this study is to look at measures that will help scientists understand the way Omalizumab, an FDA-approved anti-allergy medication, works.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2012

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

June 1, 2021

Enrollment Period

8.7 years

First QC Date

August 19, 2006

Results QC Date

December 5, 2017

Last Update Submit

June 21, 2021

Conditions

AsthmaAllergic RhinitisAtopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • FcεRI (High Affinity Receptor) Levels at 3 Months

    Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification.

    3 months

  • FcεRI (High Affinity Receptor) Levels at 6 Months

    Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification.

    6 months

Secondary Outcomes (1)

  • Total Sera IgE Levels at 6 Months

    6 months

Study Arms (2)

Omalizumab

EXPERIMENTAL

Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens

Drug: Omalizumab

Placebo

EXPERIMENTAL

Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens

Drug: Placebo

Interventions

OmalizumabDRUG

Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.

Also known as: Xolair
Omalizumab
PlaceboDRUG

Placebo, given by subcutaneous injection.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild or moderate persistent asthma
  • Allergic rhinitis
  • Atopic dermatitis

You may not qualify if:

  • Other lung diseases
  • Blood clotting disorder
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

AsthmaRhinitis, AllergicDermatitis, Atopic

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Limitations and Caveats

There are no limitations and caveats.

Results Point of Contact

Title
Fu-Tong Liu, M.D., Ph.D.
Organization
University of California-Davis, Department of Dermatology
fliu@ucdavis.edu
916-734-6556

Study Officials

  • Fu-Tong Liu, M.D., Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2006

First Posted

August 22, 2006

Study Start

February 1, 2004

Primary Completion

October 17, 2012

Study Completion

October 17, 2012

Last Updated

July 13, 2021

Results First Posted

July 13, 2021

Record last verified: 2021-06

Locations

US(1)