Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

• Status: Completed
• Trial end date: 2017-05-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Treatments: Fluticasone; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

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.)