Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT01430403
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) \[IU/mL\] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
  • Inhaled Corticosteroid Boost Therapy (ICS) — DRUG
    Self-administered fluticasone (Flovent ® Diskus®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone. All participants will receive standardized specialist asthma care.
  • Placebo omalizumab — BIOLOGICAL
    Placebo was administered subcutaneously every 2 or 4 weeks over a period of 4 to 5 months. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (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, 2007) guidelines, under the management of an asthma specialist health care provider.
  • Placebo fluticasone — BIOLOGICAL
    Self-administered placebo fluticasone (placebo Flovent ® Diskus®) inhalers identical in dose and guidance as active fluticasone. All participants will receive standardized specialist asthma care.

Study Details

The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.

Key Dates

Start date
Sep 30, 2011
Status verified
May 2017
Primary completion
Dec 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
478 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    Participants receive active omalizumab (Xolair®) injections and a placebo Flovent® Diskus® (fluticasone) inhaler. Each participant will receive omalizumab (Xolair®) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) \[IU/mL\] every 2 or 4 weeks during the 4-5 months treatment period. In addition, all participants receive standardized specialist asthma care.
  • Experimental: Inhaled Corticosteroid Boost Therapy (ICS)
    Participants in this group, the Inhaled Corticosteroid (ICS) boost arm, receive active ICS and placebo omalizumab (Xolair®) injections. Self-administered fluticasone (Flovent ® Diskus®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone will be used. In addition, all participants receive standardized specialist asthma care.
  • Placebo Comparator: Placebo
    The placebo group receive placebo omalizumab (Xolair®) injections and placebo Flovent® Diskus® (fluticasone) inhaler. In addition, all participants receive standardized specialist asthma care.

Primary Outcome Measure

Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) [ Time Frame: 90 Day outcome period ]

Locations (8)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Memorial Hospital - Department of AllergyChicagoIllinois60614-3363-
Boston University School of MedicineBostonMassachusetts02118-
Henry Ford Health SystemDetroitMichigan48202-
Columbia University Medical CenterNew YorkNew York10032-
Cincinnati Children's HospitalCincinnatiOhio45229-
University of Texas Southwestern Medical CenterDallasTexas75235-

Find similar trials in Denver, CO

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
National Jewish Health· Denver, COChildren's National Medical Center· Washington D.C., DCChildren's Memorial Hospital - Department of Allergy· Chicago, ILBoston University School of Medicine· Boston, MAHenry Ford Health System· Detroit, MIColumbia University Medical Center· New York, NY

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