A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)

Sponsor
Genentech, Inc.
Study ID
NCT00096954
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab (Xolair) — DRUG
    Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of \> 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
  • placebo — DRUG
    The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.

Study Details

This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists \[LABAs\], leukotriene receptor antagonist \[LTRA\], or immunotherapy).

Key Dates

Start date
Feb 28, 2006
Status verified
May 2017
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: Omalizumab
    Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL\] every 4 weeks.
  • Placebo Comparator: Placebo
    Placebo administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL\] every 4 weeks.

Primary Outcome Measure

Rate of Asthma Exacerbations Over the 24 Week Treatment Period [ Time Frame: Start of treatment to 24 weeks ]

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