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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01OH010404-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Occupational Safety and Health (NIOSH/CDC) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncontrolled LRS | Active Comparator | 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. |
|
| Controlled LRS | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate 230mcg for 3 Months | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 12 |
| 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Reibman, M.D | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17983880 | Background | 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. | |
| 19365288 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Visit 1 Uncontrolled LRS | Patients who have uncontrolled LRS (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. Fluticasone propionate 230mcg for 3 Months Salmeterol 21mcg for 3 Months |
| FG001 | Visit 1 Controlled LRS | 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. Current Treatment or no treatment: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visit 1 Uncontrolled LRS | Patients who have uncontrolled LRS (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. Fluticasone propionate 230mcg for 3 Months Salmeterol 21mcg for 3 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | resonant frequency | Week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uncontrolled LRS | 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. Fluticasone propionate 230mcg for 3 Months Salmeterol 21mcg for 3 Months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Reibman, MD | NYU Langone | 212-263-6479 | joan.reibman@nyumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2014 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D055118 | Medication Adherence |
| D007249 | Inflammation |
| D005767 | Gastrointestinal Diseases |
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Current Treatment or no treatment |
| Drug |
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. |
|
| Salmeterol 21mcg for 3 Months | Drug |
|
measured by laryngoscopic visualization at rest or after provocation with various odors or exercise. |
| Week 12 |
| Total IgE (Immunoglobulin E) Levels | IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL. | Week 1 |
| Total EoS (Eosinophil) Counts | EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL. | Week 1 |
| 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. | Week 12 |
| 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. | Week 12 |
| 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). | Week 12 |
| 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. | Week 12 |
| 21642248 | Background | 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. |
| BG001 | Visit 1 Controlled LRS | 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. Current Treatment or no treatment: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Visit 1 Controlled LRS |
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. Current Treatment or no treatment: 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. |
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | % FEV1(Liters)/FVC(Liters) | Week 12 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Total IgE (Immunoglobulin E) Levels | IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL. | Posted | Median | Inter-Quartile Range | ng/mL | Week 1 |
|
|
|
| Secondary | Total EoS (Eosinophil) Counts | EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL. | Posted | Median | Inter-Quartile Range | eosiniphils *10^9/Liter | Week 1 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | parts per billion (ppb) | Week 12 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on VHI-10 scale | Week 12 |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on ICSD scale | Week 12 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on LCQ scale | Week 12 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Controlled LRS | 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. Current Treatment or no treatment: 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. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D015438 | Health Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |