Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

NCT03089515 | Completed

• 1 other identifier: 16-01589
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Lower Respiratory Disease

Keywords

World Trade Center; World Trade Center Survivors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Comparison of measure of serum marker IL-6

  4 Months

• Comparison of measure of serum marker IL-8

  4 Months

• Comparison of measure of serum marker CRP

  4 Months

• Th2 inflammation By measure of fibrinogen

  4 Months

• Th2 inflammation By measure of periostin

  4 Months

Study Arms (2)

Healthy Controls

ACTIVE COMPARATOR

Other: Cardio-Pulmonary Exercise Testing (CPET)

Survivors

EXPERIMENTAL

Other: Cardio-Pulmonary Exercise Testing (CPET)

Interventions

Cardio-Pulmonary Exercise Testing (CPET) OTHER

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.

Healthy Controls; Survivors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Berger, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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)

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: September 7, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

US (1)