NCT02024204

Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases
• Medication Compliance

Interventions

Type	Name	Description
DRUG	Fluticasone propionate 230mcg for 3 Months
DRUG	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.
DRUG	Salmeterol 21mcg for 3 Months

Timeline

• Start date: 2014-04-09
• Primary completion: 2017-05-17
• Completion: 2017-05-17
• First posted: 2013-12-31
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States