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Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

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ClinicalTrials.gov Identifier: NCT03089515
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Lower Respiratory Disease Diagnostic Test: Cardio-Pulmonary Exercise Testing (CPET) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : September 7, 2019
Estimated Study Completion Date : September 7, 2019

Arm Intervention/treatment
Active Comparator: Healthy Controls Diagnostic Test: 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 Diagnostic Test: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089515


Contacts
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Contact: Karen Carapetyan 212 263 6407 karen.carapetyan@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Karen Carapetyan       karen.carapetyan@nyumc.org   
Principal Investigator: Kenneth Berger, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
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Principal Investigator: Kenneth Berger, MD New York University School of Medicine

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03089515     History of Changes
Other Study ID Numbers: 16-01589
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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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

Keywords provided by New York University School of Medicine:
World Trade Center
World Trade Center Survivors

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases