Phase 3
N=41
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01007149 ↗Enrolled (actual)
41
Serious AEs
7.3%
Results posted
Jun 2012
Primary outcome: Primary: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils — -84.4; 27.7 Percent change in MFI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- omalizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils |
-84.4; 27.7 | — |
| PRIMARY Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells |
-56.7; 24.8 | — |
| SECONDARY Change in Fractional Exhaled Nitric Oxide (FeNO) |
2.5; -5.9; 4.3; -7.4; 1.0; 1.3 | — |
| SECONDARY Change From Baseline in Induced Sputum Eosinophil Count |
-10.2; 2.2 | — |
| SECONDARY Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist) |
-0.5; -0.5; 0.1; -0.8; -0.6; -0.9 | — |
| SECONDARY Change From Baseline in Nasal Symptom Global Score and Individual Components |
-0.8; -0.3; -1.1; -0.4; -0.9; -0.6 | — |
| SECONDARY Physician and Patient Global Evaluation of Treatment Effectiveness |
2; 1; 6; 4; 3; 8 | — |
| SECONDARY Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks |
0.25; 0.00 | — |
| SECONDARY Number of Patients With at Least One Asthma-related Event Over 16 Weeks |
9; 11 | — |
Summary
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
Eligibility Criteria
Inclusion Criteria
Severe persistent asthma with the following characteristics:
- Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
- Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
- Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens
Exclusion Criteria
- Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
- Asthma exacerbation during the 4 weeks prior to randomization.
- Active lung disease other than non-atopic asthma.
- Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
- Pregnant or nursing (lactating) women.
- Treatment with omalizumab.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01007149). 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.