Inner-City Anti-IgE Therapy for Asthma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00377572
Phase
PHASE4
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 standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
  • omalizumab placebo — BIOLOGICAL
    Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.

Study Details

The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.

Key Dates

Start date
Oct 31, 2006
Status verified
Feb 2017
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
419 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab (Xolair) + Conventional Therapy
    Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
  • Placebo Comparator: Placebo + Conventional Therapy
    Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.

Primary Outcome Measure

Maximum Number of Asthma Symptom Days [ Time Frame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment. ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Arizona Health Sciences CenterTucsonArizona245018-
National Jewish Medical and Research CenterDenverColorado80206-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Memorial HospitalChicagoIllinois60614-
Boston University School of MedicineBostonMassachusetts02118-
Columbia University Medical CenterNew YorkNew York10029-
Rainbow Babies and Children's HospitalClevelandOhio44106-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Tucson, AZ

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
University of Arizona Health Sciences Center· Tucson, AZNational Jewish Medical and Research Center· Denver, COChildren's National Medical Center· Washington D.C., DCChildren's Memorial Hospital· Chicago, ILBoston University School of Medicine· Boston, MAColumbia University Medical Center· New York, NY

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