Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

NYU Langone Health

Status: Completed

Conditions: Lung Diseases; Medication Compliance

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02024204

1U01OH010404-01A1 (U.S. NIH Grant/Contract)

13-00448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Uncontrolled LRS

Active Comparator group

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.

Treatment:

Drug: Fluticasone propionate 230mcg for 3 Months

Drug: Salmeterol 21mcg for 3 Months

Controlled LRS

Other group

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.

Treatment:

Drug: Current Treatment or no treatment