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Biomarkers of Irritant-Induced and Allergic Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740543
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Asthma is a heterogeneous disease, and although much is understood about mechanisms of inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma (IA). Understanding the underlying similarities and differences in mechanisms of these two types of asthma will help focus current treatments and lead to development of new therapies. There is a longstanding NYU/Bellevue Asthma registry (NYUBAR), with a large population (N = 900) of asthma cases and controls, a program that has been housed at the CTSI (formerly GCRC). The destruction of the World Trade Center (WTC) resulted in massive dust, gas and fume exposures to local residents, workers and cleanup workers and individuals involved in rescue and recovery and adverse respiratory health effects of this disaster are reported more than 7 years after 9/11. Many responders, as well as those exposed as residents or local workers, have developed IA, asthma that arises after a lag from an environmental exposure . The WTC Environmental Health Center (WTC EHC) is one of the three New York City (NYC) WTC Centers of Excellence and the only one that focuses on treatment and monitoring of local workers and residents. As such, it has a large population of individuals with irritant-induced asthma. It has been proposed to use participants from the NYUBAR and the WTC EHC to expand the knowledge of irritant and allergic asthma. Non-invasive studies allow for the assessment of airway inflammation, a non-specific response to environmental exposure and injury. Recent technologies also allow for assessment of microRNA (miRNA), small RNAs that regulate gene expression at the post-transcriptional level and thus serve as a pathway to regulation of inflammation. The hypothesis will be tested in that airway inflammation in irritant and allergic asthma may be similar, but result from divergent miRNA regulatory pathways expressed in sputum cells. These studies will provide preliminary data for future studies that will help identify biological pathways to categorize these asthma phenotypes and target future treatment interventions.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone propionate HFA 220 Drug: Placebo Phase 2

Detailed Description:

This study will have two asthma phenotypes and one control population. Patients will be recruited from the WTC EHC = 30 with WTC dust cloud exposure, patients will be recruited from the NYUBAR (n=30) and have asthma as defined by NIH guidelines, and control patients will be recruited from the NYUBAR (n=30) and will have no respiratory sx, no asthma diagnosis, or no WTC dust exposure.

The study will entail two to three visits. On visit 1 (V1) all individuals will sign informed consent to participate in the study under an NYU IRB approved protocol. A questionnaire will be completed with standardized questions that include information on WTC exposures, demographics, presence and severity of respiratory symptoms, tobacco history and past medical history. Individuals will undergo spirometry with inhaled bronchodilator. Individuals will undergo methacholine challenge test (visit 1a) if they have normal spirometry or no bronchial hyperresponsiveness. On visit 2, individuals will return to undergo ENO, EBC and spirometry with pre and post bronchodilator maneuvers and induced sputum. Blood will be obtained for CBC with differential cell count, and assessment of total IgE and allergen-specific IgE. Blood will also be stored for future analysis of inflammatory markers. Based on experience, there have been individuals unable to produce enough sputum and thus yield too small a number of cells. These individuals are excluded from data analysis. In addition, there will also be subjects who are able to produce sputum and return for repeat sputum testing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers of Irritant-Induced and Allergic Asthma: Phase I and Phase II
Study Start Date : December 2013
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Irritant-Induced Asthma Drug: Fluticasone propionate HFA 220
Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
Other Name: Corticosteroid

Active Comparator: Allergic Asthma Drug: Fluticasone propionate HFA 220
Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
Other Name: Corticosteroid

Placebo Comparator: Irritant-Induced Asthma Control Drug: Placebo
Placebo Comparator: Allergic Asthma Control Drug: Placebo



Primary Outcome Measures :
  1. Change in TSLP Gene Expression [ Time Frame: Baseline and Two (2) weeks ]
    The primary outcome is the change in TSLP gene expression in epithelial cells after 2 weeks of treatment of inhaled corticosteroid compared to no treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Phase I

For the WTC population with Irritant-Induced Asthma (IA):

  • > 18 years of age*
  • Current nonsmoker*
  • < 5 pack year (p-y) history of tobacco use*
  • Spirometry in the past 6 months or on day of evaluation with a bronchodilator* response of ≥ 12% and 200 ml improvement in FEV*
  • Positive methacholine challenge test (decrease in FEV1*

    ≥ 20% (PC20) after inhalation of < 16 mg/ml of methacholine)

  • Inhaled corticosteroid use in previous 1 month or more will be allowed*
  • Patients will be recruited from the WTC EHC and will have WTC dust cloud exposure
  • New symptoms after 9/11
  • Symptoms of wheeze and shortness of breath (> 2x / week) in the 4 weeks before inclusion (persistent symptoms).

Inclusion for Allergic Asthma Population (AA):

  • All of the above items with an asterisk (*)
  • Patients will be recruited from the NYUBAR or advertisement and will have asthma as defined by NIH guidelines, persistent symptoms, absence of WTC dust exposure.
  • Participants who will have completed the Phase I of the study and were able to produce adequate sputum samples.

Inclusion of Control Population:

  • Patients will be recruited from the NYUBAR and will have no respiratory symptoms, no asthma diagnosis, no WTC dust exposure, no current tobacco use, ≤ 5 p-y history of tobacco use, and normal spirometry with no bronchodilator response and negative methacholine challenge in past 6 months.

Inclusion Criteria for Phase II:

  • Successfully completed Phase I
  • Has asthma according to Phase I diagnostic criteria
  • Signed consent to be re-contacted

Exclusion Criteria:

  • Current Smoker
  • Pulmonary diseases such as Chronic Pulmonary Disease (COPD) or Interstitial Lung Disease
  • Cardiac Disease
  • Inability to perform lung function or other maneuvers
  • Upper respiratory tract infection within the last 4 weeks
  • FEV1 <60% predicted normal pre-bronchodilator
  • Oral corticosteroid treatment within the last 4 weeks.
  • No vulnerable subjects will be part of this study.

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): NCT02740543


Locations
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United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Angeliki Kazeros, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02740543    
Other Study ID Numbers: 10-01191
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Keywords provided by NYU Langone Health:
World Trade Center
WTC
Induced Sputum
Exhaled Breath Condensate
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents