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Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

Primary Purpose

Chronic Obstructive Pulmonary Disease, Lower Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardio-Pulmonary Exercise Testing (CPET)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring World Trade Center, World Trade Center Survivors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

sACOS patients

  • Previously participated in ULRS study and signed consent to be recontacted, or
  • Patient in the WTC EHC and signed consent to be recontacted
  • Onset of lower respiratory symptoms (LRS) after 9/11/01
  • ACT < 20 at WTC EHC Monitoring visit
  • Presence of LRS on Study Visit 1
  • ACT<20 at Study Visit 1
  • FEV1 > 70% predicted Study Visit 1
  • Using ICS/LABA (Advair HFA equivalent > 115/21 mcg bid) or Fluticasone (110 mcg bid or equivalent) for at least 1 month before Study Visit 1
  • CXR without parenchymal abnormalities

Control

  • Patient in the WTC EHC and signed consent to be recontacted
  • of lower respiratory symptoms on WTC EHC Monitoring Visit of WTC EHC
  • Absence of lower respiratory symptoms on Study Visit 1
  • FEV1 > 70% predicted on monitoring
  • Not on any ICS/LABA/LAMA

Exclusion Criteria:

sACOS

  • >10py tobacco use
  • Unstable cardiac disease
  • Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg
  • Oxygen saturation < 90%
  • Uncontrolled HTN, DM
  • Musculoskeletal inability to exercise
  • Use of long acting muscarinic antagonist in the past 2 weeks
  • Current use of oral corticosteroids
  • Other pulmonary disease, including sarcoidosis, ILD
  • Currently pregnant or with plans to become pregnant or lactating
  • History of narrow angle glaucoma
  • Known prostate hyperplasia or bladder-neck obstruction

Control

  • >10py tobacco use
  • Unstable cardiac disease
  • Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg
  • Oxygen saturation < 90%
  • Uncontrolled HTN, DM
  • Musculoskeletal inability to exercise
  • Use of ICS/LABA/SABA/LAMA individually or in combined formulation
  • Current use of oral corticosteroids
  • Other pulmonary disease, including sarcoidosis, ILD
  • Currently pregnant or with plans to become pregnant or lactating
  • History of narrow angle glaucoma
  • Known prostate hyperplasia or bladder-neck obstruction

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Controls

Survivors

Arm Description

Outcomes

Primary Outcome Measures

Resting Lung Function using Spirometry following Forced Oscillation Techniques
functional impairment at rest and with increased respiratory frequency (spirometry and forced oscillation techniques; FOT).
Measure of Lung Function using spirometry after inhalation of a targeted anti-muscarinic agent.
Spirometry (meaning the measuring of breath) is the most common of the pulmonary function tests (PFTs), measuring lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

Secondary Outcome Measures

Comparison of measure of serum marker IL-6
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Comparison of measure of serum marker IL-8
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Comparison of measure of serum marker CRP
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Th2 inflammation By measure of fibrinogen
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Th2 inflammation By measure of periostin
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.

Full Information

First Posted
March 20, 2017
Last Updated
January 7, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03089515
Brief Title
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Official Title
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many "Survivors" in the World Trade Center (WTC) clinical program have a clinical syndrome characterized by chronic obstruction in small airways and persistence of lower respiratory symptoms despite therapy. This study will test the hypothesis that persistent symptoms in WTC "Survivors" are associated with abnormal small airways whose dysfunction is amplified during exercise and is associated with biologic evidence of inflammation and remodeling. The results from this study will have important treatment implications for our WTC population with potential applicability to larger populations with either inhalational lung injury and/or airway diseases such as asthma and chronic obstructive pulmonary disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Lower Respiratory Disease
Keywords
World Trade Center, World Trade Center Survivors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Healthy Controls who were not in the WTC program (n = 20) Uncontrolled Lower Respiratory Symptoms in WTC Surivivors; ULRS study) with persistent LRS (n = 40)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Title
Survivors
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cardio-Pulmonary Exercise Testing (CPET)
Intervention Description
This test helps determine if the decreased tolerance to exercise or shortness of breath with activity a patient is experiencing is caused by a cardiac disease, versus a pulmonary disease.
Primary Outcome Measure Information:
Title
Resting Lung Function using Spirometry following Forced Oscillation Techniques
Description
functional impairment at rest and with increased respiratory frequency (spirometry and forced oscillation techniques; FOT).
Time Frame
4 Months
Title
Measure of Lung Function using spirometry after inhalation of a targeted anti-muscarinic agent.
Description
Spirometry (meaning the measuring of breath) is the most common of the pulmonary function tests (PFTs), measuring lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Comparison of measure of serum marker IL-6
Description
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Time Frame
4 Months
Title
Comparison of measure of serum marker IL-8
Description
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Time Frame
4 Months
Title
Comparison of measure of serum marker CRP
Description
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Time Frame
4 Months
Title
Th2 inflammation By measure of fibrinogen
Description
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Time Frame
4 Months
Title
Th2 inflammation By measure of periostin
Description
Inflammation is caused by extra protein released from the site of inflammation that circulates in the bloodstream. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and plasma viscosity (PV) blood tests are commonly used to detect this increase in protein. In this way they are used as markers of inflammation.
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: sACOS patients Previously participated in ULRS study and signed consent to be recontacted, or Patient in the WTC EHC and signed consent to be recontacted Onset of lower respiratory symptoms (LRS) after 9/11/01 ACT < 20 at WTC EHC Monitoring visit Presence of LRS on Study Visit 1 ACT<20 at Study Visit 1 FEV1 > 70% predicted Study Visit 1 Using ICS/LABA (Advair HFA equivalent > 115/21 mcg bid) or Fluticasone (110 mcg bid or equivalent) for at least 1 month before Study Visit 1 CXR without parenchymal abnormalities Control Patient in the WTC EHC and signed consent to be recontacted of lower respiratory symptoms on WTC EHC Monitoring Visit of WTC EHC Absence of lower respiratory symptoms on Study Visit 1 FEV1 > 70% predicted on monitoring Not on any ICS/LABA/LAMA Exclusion Criteria: sACOS >10py tobacco use Unstable cardiac disease Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg Oxygen saturation < 90% Uncontrolled HTN, DM Musculoskeletal inability to exercise Use of long acting muscarinic antagonist in the past 2 weeks Current use of oral corticosteroids Other pulmonary disease, including sarcoidosis, ILD Currently pregnant or with plans to become pregnant or lactating History of narrow angle glaucoma Known prostate hyperplasia or bladder-neck obstruction Control >10py tobacco use Unstable cardiac disease Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg Oxygen saturation < 90% Uncontrolled HTN, DM Musculoskeletal inability to exercise Use of ICS/LABA/SABA/LAMA individually or in combined formulation Current use of oral corticosteroids Other pulmonary disease, including sarcoidosis, ILD Currently pregnant or with plans to become pregnant or lactating History of narrow angle glaucoma Known prostate hyperplasia or bladder-neck obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Berger, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

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