At a glance
ClinicalIndex Comparison Record- ✓Documented asthma history with ≥12% FEV1 reversibility (demonstrated by albuterol response, improvement around exacerbation, or screening measurement)
- ✓Baseline FEV1 ≥80% predicted normal value prior to randomization
- ✓Positive skin test (wheal ≥3 mm) or RAST/ImmunoCap to a relevant perennial aeroallergen (e.g., cat, dust mites) within past year
- ✓Currently receiving inhaled corticosteroid at fluticasone DPI ≥200 µg/day (or equivalent) for ≥12 weeks before screening
- ✕Chronic systemic corticosteroids (oral or IV) within 3 months, or burst of oral corticosteroids within last 2 weeks before screening
- ✕Prior omalizumab (Xolair) therapy within 12 months before screening
- ✕Known hypersensitivity to omalizumab or its excipients (sucrose, histidine, polysorbate 20)
- ✕Lifetime smoking history >10 pack-years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating omalizumab (Xolair) and placebo for Asthma. Completed, enrolled 333 participants.
Detailed Summary
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).
Study Details
Timeline
Interventions
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.
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.