A Phase 4 interventional study of Omalizumab and Placebo in Asthma, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
The primary purpose of this study is to identify additional mechanisms of action of omalizumab that will lead to improved stratification of patients for treatment. Understanding the response of specific innate immune effector cells in the lung can provide clues to these questions. Investigators will use non-invasive measures of a discrete cell population to examine the downstream effects of omalizumab treatment in the lung. Information derived from these studies will help clarify mechanisms of action of omalizumab and help identify potential tools for patient endotyping and stratification for therapeutic interventions.
This is a randomized, placebo-controlled, double blind, 16-week intervention study to show feasibility and proof of concept. Analysis of whole induced sputum is under development for endotyping for asthma, allowing sampling of rare cells from conducting airways, repeated sampling, and cell-specific detailed genomic evaluation. Investigators have developed a novel technique to simultaneously enrich innate immune cells from sputum. This technique allows for in situ analyses of sputum-derived human bronchial epithelial cells (sHBEC). The non-invasive nature of the technique provides a unique tool for in vivo human studies.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 3 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Omalizumab
Drug: Placebo
Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
Also known as: Xolair, corticosteroids
Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
Also known as: Saline
Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Two Group T-test in Moderate Persistent Asthma
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Two Group T-test in Moderate Persistent Asthma
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma
Time frame: 16 Weeks of Treatment of omalizumab or placebo
The Effect of Omalizumab on Changes sHBEC Targets (Gene Expression Array) Compared Using Two-group T-test if Data
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Change in Score on Asthma Control Test
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Change in Lung Function Measure by Spirometry Test
Time frame: 16 Weeks of Treatment of omalizumab or placebo
Change in Measures of Small Airway Dysfunction Using Impulse Oscillometry
Time frame: 16 Weeks of Treatment of omalizumab or placebo
The Effect of Omalizumab on Newly Identified sHBEC Targets (Gene Expression) Analyzed Using Cufflinks.
Time frame: 16 Weeks of Treatment of omalizumab or placebo
The Effect of Omalizumab on Newly Identified sHBEC Targets (Gene Expression) Analyzed Using Gene Analyses
Time frame: 16 Weeks of Treatment of omalizumab or placebo
The Effect of Omalizumab on Gene "Signature" Generation Analyzed Using Gene Analysis Techniques
Time frame: 16 Weeks of Treatment of omalizumab or placebo
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 3 | 0 |
| Completed | 3 | 0 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 60 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omalizumab | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Placebo | — | — | — |
None were on placebo because study had a block randomization of 6.
| Age, Categorical(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| United States | 3 | 0 | 3 |
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This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab