Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Lower Respiratory Disease
• Intervention / Treatment: Other: Cardio-Pulmonary Exercise Testing (CPET)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Controls	Other: Cardio-Pulmonary Exercise Testing (CPET); 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.
Experimental: Survivors	Other: Cardio-Pulmonary Exercise Testing (CPET); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Lung Function using Spirometry following Forced Oscillation Techniques	functional impairment at rest and with increased respiratory frequency (spirometry and forced oscillation techniques; FOT).	4 Months
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.	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 Months
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.	4 Months
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.	4 Months
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.	4 Months
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.	4 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kenneth Berger, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: World Trade Center; World Trade Center Survivors
• Additional Relevant MeSH Terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 16-01589

Drug and device information, study documents

• 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