Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00078195
Phase
PHASE2
Status
Completed

Conditions

  • Allergy
  • Hay Fever
  • Hypersensitivity
  • Rhinitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — BIOLOGICAL
    A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
  • Placebo omalizumab — BIOLOGICAL
    The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
  • Ragweed rush immunotherapy (RIT) — BIOLOGICAL
    RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
  • Placebo rush immunotherapy (RIT) — BIOLOGICAL
    The placebo for rush immunotherapy will contain the diluents and histamine.
  • Ragweed immunotherapy (IT) — BIOLOGICAL
    Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
  • Placebo immunotherapy (IT) — BIOLOGICAL
    The placebo for immunotherapy will contain the diluents and histamine.

Study Details

A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.

Key Dates

Start date
Apr 30, 2003
Status verified
Oct 2016
Primary completion
May 31, 2005
Completion
May 31, 2005

Study Design

Enrollment
168 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT
    Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT).
  • Experimental: Omalizumab pre-treatment, omalizumab
    Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT).
  • Active Comparator: Ragweed RIT, ragweed IT
    Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT).
  • Placebo Comparator: Placebo
    Participants are pre-treated with placebo omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus placebo immunotherapy (IT).

Primary Outcome Measure

Average daily allergy severity score [ Time Frame: 2003 ragweed pollen season ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-
Creighton UniversityOmahaNebraska68131-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IACreighton University· Omaha, NEUniversity of Wisconsin· Madison, WI

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