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Sputum-derived Cellular Targets After Xolair (Omalizumab)

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Xolair, corticosteroids, asthma, long-acting beta-agonists

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Physician diagnosed asthma
Lung function (one or more of the following documented in the 5 years before enrollment or demonstration during screening) 1. Bronchial hyper responsiveness (BhR) confirmed by ≥ 12% improvement in FEV1 post bronchodilator within the previous 5 years, or 2. Methacholine PC20 < 16mg/dl within the previous 5 years
Severity Criteria: Moderate-persistent asthma defined by the American Thoracic Society (ATS)
Asthma Control: Partly or uncontrolled asthma according to GINA 2012 guidelines (at least three of the following features: daytime symptoms more than 2 times/week, limitation of activities, nocturnal symptoms, need for rescue inhaler > 2 times/week, FEV1 <80% predicted)
Stable use of moderate-high dose inhaled corticosteroids in previous 3 months (definition derived from GINA 2012 guidelines: e.g. fluticasone propionate >250 mcg/day, budesonide > 400mcg/day)
Ability to perform induced sputum maneuvers
Presence of elevated allergen IgE to any perennial aeroallergen

Exclusion Criteria:

Pulmonary function: FEV1 ≤ 70% predicted
Any major chronic illness including but not limited to Chronic Obstructive Pulmonary Disease (COPD), uncontrolled hypertension, coronary artery disease, bronchiectasis, congestive heart failure, stroke, cystic fibrosis, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency state, or other condition that would interfere with participation in the study
Current or > 10 pack a year pack-year tobacco use
Any investigational study within previous 1 month
Inability to perform baseline measurements
Inability to contact by telephone
Pregnancy at screening and failure to use double barrier pregnancy protection in woman of childbearing age
Hypersensitivity reaction to omalizumab in the past
Exceeds limits of dosing table (IgE <30 or 700 IU/ml) or body weight of <30 or > 150kg
Systemic corticosteroids within the previous month
Known malignant neoplasm

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omalizumab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Two Group T-test in Moderate Persistent Asthma

Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma

Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Two Group T-test in Moderate Persistent Asthma

Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma

Secondary Outcome Measures

The Effect of Omalizumab on Changes sHBEC Targets (Gene Expression Array) Compared Using Two-group T-test if Data

Change in Score on Asthma Control Test

Change in Lung Function Measure by Spirometry Test

Change in Measures of Small Airway Dysfunction Using Impulse Oscillometry

Full Information

NCT ID

NCT02658877

First Posted

December 17, 2015

Last Updated

September 25, 2019

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02658877

Brief Title

Sputum-derived Cellular Targets After Xolair (Omalizumab)

Official Title

In Situ Analysis of Sputum-derived Cellular Targets After Xolair (Omalizumab).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Difficulty recruiting subjects

Study Start Date

January 2016 (undefined)

Primary Completion Date

July 19, 2018 (Actual)

Study Completion Date

July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Xolair, corticosteroids, asthma, long-acting beta-agonists

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair, corticosteroids

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

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