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Sputum-derived Cellular Targets After Xolair (Omalizumab)

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ClinicalTrials.gov Identifier: NCT02658877
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Omalizumab Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: In Situ Analysis of Sputum-derived Cellular Targets After Xolair (Omalizumab).
Study Start Date : January 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Omalizumab Drug: Omalizumab
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.
Other Names:
  • Xolair
  • corticosteroids

Placebo Comparator: Placebo Drug: Placebo
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.
Other Name: Saline




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in score on Asthma Control Test [ Time Frame: 16 Weeks of Treatment of omalizumab or placebo ]
  3. Change in lung function measure by spirometry test [ Time Frame: 16 Weeks of Treatment of omalizumab or placebo ]
  4. Change in measures of small airway dysfunction using impulse oscillometry [ Time Frame: 16 Weeks of Treatment of omalizumab or placebo ]

Other Outcome Measures:
  1. The effect of omalizumab on newly identified sHBEC targets (gene expression) analyzed using cufflinks. [ Time Frame: 16 Weeks of Treatment of omalizumab or placebo ]
  2. 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 ]
  3. The effect of omalizumab on gene "signature" generation analyzed using gene analysis techniques [ Time Frame: 16 Weeks of Treatment of omalizumab or placebo ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658877


Contacts
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Contact: Karen Carapetyan carapk01@nyumc.org
Contact: Shanni Subryan, MD subryc01@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Karen Carapetyan       carapk01@nyumc.org   
Contact: Bertram Bleck       bleckb01@nyumc.org   
Principal Investigator: Joan Reibman, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
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Principal Investigator: Joan Reibman, MD New York University Medical School

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02658877     History of Changes
Other Study ID Numbers: 14-01160
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Keywords provided by New York University School of Medicine:
Xolair
corticosteroids
asthma
long-acting beta-agonists

Additional relevant MeSH terms:
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Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents