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Completed

NCT Number: NCT03089515

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Resting Lung Function using Spirometry following Forced Oscillation Techniques

    Time frame: 4 Months

    functional impairment at rest and with increased respiratory frequency (spirometry and forced oscillation techniques; FOT).

  2. Measure of Lung Function using spirometry after inhalation of a targeted anti-muscarinic agent.

    Time frame: 4 Months

    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 outcomes

  1. Comparison of measure of serum marker IL-6

    Time frame: 4 Months

    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.

  2. Comparison of measure of serum marker IL-8

    Time frame: 4 Months

    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.

  3. Comparison of measure of serum marker CRP

    Time frame: 4 Months

    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. Th2 inflammation By measure of fibrinogen

    Time frame: 4 Months

    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.

  5. Th2 inflammation By measure of periostin

    Time frame: 4 Months

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2017
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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