Biomarkers of Irritant-Induced and Allergic Asthma

NCT02740543 | Completed Phase 2 Results

• 1 other identifier: 10-01191
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

World Trade Center; WTC; Induced Sputum; Exhaled Breath Condensate

Outcome Measures

Primary Outcomes (1)

• Change in TSLP Gene Expression

  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.

  Baseline and Two (2) weeks

Study Arms (2)

Allergic Asthma (AA)

ACTIVE COMPARATOR

Drug: Fluticasone propionate HFA 220

Control

NO INTERVENTION

Interventions

Fluticasone propionate HFA 220 DRUG

Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.

Also known as: Corticosteroid

Allergic Asthma (AA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.
• Successfully completed Phase I

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Angeliki Kazeros, MD
• Organization: NYU Langone Health - Bellevue Hospital

Angeliki.Kazeros@nyulangone.org

212-263-6479

Study Officials

• Angeliki Kazeros, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 15, 2016
• Study Start: December 1, 2013
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: September 13, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Locations

US (1)