Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program (NCT02024204) | Clinical Trial Compass
CompletedNot Applicable
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
United States60 participantsStarted 2014-04-09
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.