Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

NYU Langone Health

Status: Completed

Conditions: Lower Respiratory Disease; Chronic Obstructive Pulmonary Disease

Treatments: Other: Cardio-Pulmonary Exercise Testing (CPET)

Study type: Interventional

Funder types: Other

Identifiers

NCT03089515

16-01589

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Healthy Controls

Active Comparator group

Treatment:

Other: Cardio-Pulmonary Exercise Testing (CPET)

Survivors

Experimental group

Treatment:

Other: Cardio-Pulmonary Exercise Testing (CPET)