Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089515
• Other study ID #: 16-01589
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lower Respiratory Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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