Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/7/2018 |
| Start Date: | September 7, 2017 |
| End Date: | September 7, 2019 |
| Contact: | Karen Carapetyan |
| Email: | karen.carapetyan@nyumc.org |
| Phone: | 212 263 6407 |
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Kenneth Berger, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
