Clinical trial NCT03089515: Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Official title: Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lower Respiratory Disease
Keywords: World Trade Center
World Trade Center Survivors
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Resting Lung Function using Spirometry following Forced Oscillation Techniques
timeFrame: 4 Months
measure: Measure of Lung Function using spirometry after inhalation of a targeted anti-muscarinic agent.
timeFrame: 4 Months
Secondary outcomes:
measure: Comparison of measure of serum marker IL-6
timeFrame: 4 Months
measure: Comparison of measure of serum marker IL-8
timeFrame: 4 Months
measure: Comparison of measure of serum marker CRP
timeFrame: 4 Months
measure: Th2 inflammation By measure of fibrinogen
timeFrame: 4 Months
measure: Th2 inflammation By measure of periostin
timeFrame: 4 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kenneth Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: