Chronic Obstructive Pulmonary DiseaseNCT03089515
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
A study testing Cardio-Pulmonary Exercise Testing (CPET) in people with Chronic Obstructive Pulmonary Disease and Lower Respiratory Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lower Respiratory Disease
- What is being tested?
- Cardio-Pulmonary Exercise Testing (CPET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- sACOS
- >10py tobacco use
- Unstable cardiac disease
- Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg
- Oxygen saturation < 90%
- Uncontrolled HTN, DM
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- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Being tested
- Cardio-Pulmonary Exercise Testing (CPET)
- Keywords
- World Trade Center, World Trade Center Survivors
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-Pulmonary Exercise Testing (CPET)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | Not described Receives: Other: Cardio-Pulmonary Exercise Testing (CPET) |
| Survivors | Experimental | Not described Receives: Other: Cardio-Pulmonary Exercise Testing (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Lung Function using Spirometry following Forced Oscillation Techniques
functional impairment at rest and with increased respiratory frequency (spirometry and forced oscillation techniques; FOT).
Measured: 4 Months
Measure of Lung Function using spirometry after inhalation of a targeted anti-muscarinic agent.
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.
Measured: 4 Months
Secondary outcomes (5)
Comparison of measure of serum marker IL-6
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.
Measured: 4 Months
Comparison of measure of serum marker IL-8
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.
Measured: 4 Months
Comparison of measure of serum marker CRP
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.
Measured: 4 Months
Th2 inflammation By measure of fibrinogen
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.
Measured: 4 Months
Th2 inflammation By measure of periostin
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.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start7 Sep 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Berger, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089515
- Sponsor's protocol ID
- 16-01589
- Status last verified
- Jan 2022
- First submitted
- 20 Mar 2017
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
- ClinicalTrials.gov ID
- NCT03089515
- Acronym / sponsor ID
- 16-01589
- Keywords
- World Trade Center, World Trade Center Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | Other: Cardio-Pulmonary Exercise Testing (CPET) |
| Survivors | Experimental | Other: Cardio-Pulmonary Exercise Testing (CPET) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (26 listed)
- sACOS
- >10py tobacco use
- Unstable cardiac disease
- Systolic BP > 180 mmHg or Diastolic BP > 120 mmHg
- Oxygen saturation < 90%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy Controls, Survivors |
Primary outcome
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.
5 secondary outcomes
Comparison of measure of serum marker IL-6
Time frame: 4 Months
Comparison of measure of serum marker IL-8
Time frame: 4 Months
Comparison of measure of serum marker CRP
Time frame: 4 Months
Th2 inflammation By measure of fibrinogen
Time frame: 4 Months
Th2 inflammation By measure of periostin
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Berger, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-Pulmonary Exercise Testing (CPET) in people with Chronic Obstructive Pulmonary Disease and Lower Respiratory Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Lung Function using Spirometry following Forced Oscillation Techniques (time frame: 4 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.