Sputum-derived Cellular Targets After Xolair (Omalizumab)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02658877
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Sep 2019
Primary completion
Jul 19, 2018
Completion
Jul 19, 2018

Study Design

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

Arms

  • Experimental: Omalizumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
New York University School of Medicine· New York, NY

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