Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Resting Lung Function using Spirometry following Forced Oscillation Techniques
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
- •>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
- •>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
Arms & Interventions
Healthy Controls
Intervention: Cardio-Pulmonary Exercise Testing (CPET) (Other)
Survivors
Intervention: Cardio-Pulmonary Exercise Testing (CPET) (Other)
Outcomes
Primary Outcomes
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).
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
- Th2 inflammation By measure of fibrinogen(4 Months)
- 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 periostin(4 Months)