Phase 4
Completed N=31
Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
Source: ClinicalTrials.gov NCT00454051 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Aug 2011
Primary outcomePrimary: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo — -0.1; 3.9; -5.9; 14.8 percent change in FcεRI expression
Summary
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo |
-0.1; 3.9; -5.9; 14.8 | — |
| PRIMARY Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo |
-77.5; 20.0; -41.4; 36.7 | — |
| SECONDARY Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment |
1.9; -5.2; 2.5; 0.9; 3.7; -6.4 | — |
| SECONDARY Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment |
-85.1; -45.8; -81.0; -11.5; -86.8; -24.2 | — |
| SECONDARY Change From Baseline in the Number of Days With Asthma Symptoms Per Week |
5.9; 4.5; -2.3; -0.9 | — |
| SECONDARY Change From Baseline in the Number of Puffs of Rescue Medication Per Week |
19.7; 10.5; -2.0; -2.7 | — |
| SECONDARY Change From Baseline in the Number of Nights With Awakenings Per Week |
2.5; 1.7; -1.2; -0.4 | — |
| SECONDARY Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week |
4.9; 4.5; -1.6; -1.0 | — |
| SECONDARY Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms |
2.7; 2.5; -0.9; 0.1 | — |
| SECONDARY Change From Baseline in the Number of Days With Hospitalizations |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in the Number of Unscheduled Clinic Visits |
0.2; 0.1; -0.1; 0.1 | — |
| SECONDARY Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF) |
303.5; 317.8; 9.9; 10.5 | — |
| SECONDARY Physician's Overall Assessment of Treatment Effectiveness |
3; 1; 5; 2; 6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Adults aged >= 18 years.
- Patients with severe persistent allergic asthma with the following characteristics:
- FEV1 (Forced Expiratory Volume in One Second) =4 days/week on average) or nocturnal awakening (>=1/week on average).
- Multiple severe asthma exacerbations: either >=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
- Despite a high dose inhaled corticosteroid >1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
- With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
- Total serum IgE level >= 30 to 20 pack years.
- Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
- History of food or drug related severe anaphylactoid or anaphylactic reaction
- Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
- Patients with active cancer, suspicion of cancer or any history of cancer.
- Pregnant women.
- Known hypersensitivity to omalizumab or to one of its components.
- Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
- Patients who had participated in a clinical trial in the past 3 months.
Data sourced from ClinicalTrials.gov (NCT00454051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.