ICATA Asthma Mechanistic Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00377390
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit, as a part of ICATA (ICAC-08, NCTNCT00377572).

Study Details

The purposes of this study are to determine the effects of omalizumab on cells involved in the allergic response, to evaluate predictors of response to omalizumab, and to determine whether response to omalizumab therapy is influenced by the environment. A subset of inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for Asthma (a clinical trial of omalizumab) will be enrolled in this study.

Key Dates

Start date
Oct 31, 2006
Status verified
Feb 2013
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
224 participants (actual)

Arms

  • Arm: Cockroach sensitive
  • Arm: Control (cockroach insensitive)

Primary Outcome Measure

Correlation of changes in basophil receptor occupancy with a reduction in maximum symptom days, inhaled corticosteroid dosage, sputum, and peripheral blood eosinophils, and frequency of exacerbations [ Time Frame: 1.5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Memorial HospitalChicagoIllinois60614-
Mount Sinai School of MedicineNew YorkNew York10029-
Rainbow Babies and Children's HospitalClevelandOhio44106-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Chicago, IL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Children's Memorial Hospital· Chicago, ILMount Sinai School of Medicine· New York, NYRainbow Babies and Children's Hospital· Cleveland, OHUniversity of Texas Southwestern Medical Center· Dallas, TX

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