Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

Not Applicable

Completed

Conditions: Lung Diseases
Medication Compliance

Interventions: Drug: Fluticasone propionate 230mcg for 3 Months
Drug: Current Treatment or no treatment
Drug: Salmeterol 21mcg for 3 Months

Registration Number: NCT02024204

Lead Sponsor: NYU Langone Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncontrolled LRS	Salmeterol 21mcg for 3 Months	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.
Uncontrolled LRS	Fluticasone propionate 230mcg for 3 Months	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	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 Outcome Measures

Name	Time	Method
Spirometry Measures	Week 12	Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters). FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity
Forced Oscillation Technique (FOT) Measures	Week 12	Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).

Secondary Outcome Measures

Name	Time	Method
Total IgE (Immunoglobulin E) Levels	Week 1	IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Total EoS (Eosinophil) Counts	Week 1	EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Score on Voice Handicap Index 10 (VHI-10)	Week 12	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)	Week 12	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)	Week 12	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.
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)	Week 12	measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Levels of Fractional Exhaled Nitric Oxide (FeNO)	Week 12	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.
Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)	Week 12	To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.