Back to resultsUncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Primary Purpose
Lung Diseases, Medication Compliance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluticasone propionate 230mcg for 3 Months
Current Treatment or no treatment
Salmeterol 21mcg for 3 Months
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring World Trade Center Disaster, Environmental Exposure, Respiratory Physiology, Inflammation, Gastrointestinal Diseases, Sinus Symptoms, PTSD, Anxiety, Depression, Hypersensitivity, Spirometry, Oscillometry
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and <75
- Meet criteria for World Trade Center Environmental Health Center enrollment
- Onset of lower respiratory symptoms after 9/11/01
- Persistent lower respiratory symptoms (> 2 times per week)
- Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits
- < 5 pack-year tobacco history
- Not current smoker
- Asthma Control Test Score ≤ 19
- Normal chest x-ray
Exclusion Criteria:
- Age < 18 years and ≥75
- Lower respiratory symptoms or asthma history pre 9/11/01
- No persistent lower respiratory symptoms
- pre-bronchodilator FEV1 within normal limits
- > 5 pack year tobacco
- Current smoker
- Abnormal Chest X-Ray or parenchymal changes on high resolution computed tomography
- Uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer)
- History of significant non-World Trade Center occupational or environmental exposure
- Allergy to study drug
- Pregnancy, lactation or plans to become pregnant
- Chronic oral corticosteroid use
- High risk of fatal or near-fatal asthma within the previous 2 years
- Other lung disease (Idiopathic pulmonary fibrosis,sarcoid, etc.)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Uncontrolled LRS
Controlled LRS
Arm Description
Patients who have uncontrolled lower respiratory symptoms (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Outcomes
Primary Outcome Measures
Forced Oscillation Technique (FOT) Measures
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Spirometry Measures
Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters).
FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity
Secondary Outcome Measures
Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Total IgE (Immunoglobulin E) Levels
IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Total EoS (Eosinophil) Counts
EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Levels of Fractional Exhaled Nitric Oxide (FeNO)
Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.
Score on Voice Handicap Index 10 (VHI-10)
Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score > 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).
Score on Leicester Cough Questionnaire (LCQ)
For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.
Full Information
NCT ID
NCT02024204
First Posted
December 18, 2013
Last Updated
January 12, 2021
Sponsor
NYU Langone Health
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
1. Study Identification
Unique Protocol Identification Number
NCT02024204
Brief Title
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Official Title
Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2014 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to understand why patients in the World Trade Center program have continuing breathing problems. This study will improve investigators understanding of breathing problems among individuals with World Trade Center exposure by allowing them to review and monitor medication use, lung function, and examine other conditions that can contribute to problems with breathing. The findings from the study will help investigators understand why some people have persistent lower respiratory symptoms (breathing problems) after their exposure to World Trade Center dust and fumes, and may help guide better management and treatment of these symptoms.
Detailed Description
Investigators will conduct a clinical study with aggressive treatment for lower respiratory symptoms in patients in the World Trade Center Environmental Health Center. Patients in the WTC EHC with uncontrolled LRS at visit 1 will be identified and placed on high-dose inhaled corticosteroids and long-acting beta agonists for three months. Adherence will be assessed at monthly visits. Patients will perform spirometry and oscillometry at baseline and after 3 months of treatment. They will also be assessed for markers of airway inflammation, bronchial hyperresponsiveness and co-morbid conditions including depression,anxiety,post-traumatic stress disorder, gastroesophageal reflux, paradoxical vocal cord motion and rhinosinusitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Medication Compliance
Keywords
World Trade Center Disaster, Environmental Exposure, Respiratory Physiology, Inflammation, Gastrointestinal Diseases, Sinus Symptoms, PTSD, Anxiety, Depression, Hypersensitivity, Spirometry, Oscillometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uncontrolled LRS
Arm Type
Active Comparator
Arm Description
Patients who have uncontrolled lower respiratory symptoms (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Arm Title
Controlled LRS
Arm Type
Other
Arm Description
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate 230mcg for 3 Months
Other Intervention Name(s)
Advair HFA
Intervention Type
Drug
Intervention Name(s)
Current Treatment or no treatment
Intervention Description
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Intervention Type
Drug
Intervention Name(s)
Salmeterol 21mcg for 3 Months
Primary Outcome Measure Information:
Title
Forced Oscillation Technique (FOT) Measures
Description
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Time Frame
Week 12
Title
Spirometry Measures
Description
Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters).
FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Description
To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
Time Frame
Week 12
Title
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
Description
measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Time Frame
Week 12
Title
Total IgE (Immunoglobulin E) Levels
Description
IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Time Frame
Week 1
Title
Total EoS (Eosinophil) Counts
Description
EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Time Frame
Week 1
Title
Levels of Fractional Exhaled Nitric Oxide (FeNO)
Description
Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.
Time Frame
Week 12
Title
Score on Voice Handicap Index 10 (VHI-10)
Description
Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score > 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.
Time Frame
Week 12
Title
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
Description
For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).
Time Frame
Week 12
Title
Score on Leicester Cough Questionnaire (LCQ)
Description
For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years and <75
Meet criteria for World Trade Center Environmental Health Center enrollment
Onset of lower respiratory symptoms after 9/11/01
Persistent lower respiratory symptoms (> 2 times per week)
Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits
< 5 pack-year tobacco history
Not current smoker
Asthma Control Test Score ≤ 19
Normal chest x-ray
Exclusion Criteria:
Age < 18 years and ≥75
Lower respiratory symptoms or asthma history pre 9/11/01
No persistent lower respiratory symptoms
pre-bronchodilator FEV1 within normal limits
> 5 pack year tobacco
Current smoker
Abnormal Chest X-Ray or parenchymal changes on high resolution computed tomography
Uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer)
History of significant non-World Trade Center occupational or environmental exposure
Allergy to study drug
Pregnancy, lactation or plans to become pregnant
Chronic oral corticosteroid use
High risk of fatal or near-fatal asthma within the previous 2 years
Other lung disease (Idiopathic pulmonary fibrosis,sarcoid, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Reibman, M.D
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17983880
Citation
National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
Results Reference
background
PubMed Identifier
19365288
Citation
Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b.
Results Reference
background
PubMed Identifier
21642248
Citation
Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC.
Results Reference
background
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Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
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