Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

Lung Diseases Clinical Trial

Official title:

Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024204
• Other study ID #: 13-00448
• Secondary ID: 1U01OH010404-01A
• Status: Completed
• Phase: N/A
• Start date: April 9, 2014
• Est. completion date: May 17, 2017

Study information

• Verified date: January 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Lung Diseases
• Medication Compliance
• Signs and Symptoms, Respiratory

Intervention

Drug:
• Fluticasone propionate 230mcg for 3 Months

• 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.
• Salmeterol 21mcg for 3 Months

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Week 12
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	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.	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.	Week 12
Secondary	Total IgE (Immunoglobulin E) Levels	IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.	Week 1
Secondary	Total EoS (Eosinophil) Counts	EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.	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.	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.	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).	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.	Week 12