Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Spirometry Measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
Uncontrolled LRS
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.
干预措施: Fluticasone propionate 230mcg for 3 Months (Drug)
Uncontrolled LRS
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.
干预措施: Salmeterol 21mcg for 3 Months (Drug)
Controlled LRS
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.
干预措施: Current Treatment or no treatment (Drug)
结局指标
主要结局
Spirometry Measures
时间窗: 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
时间窗: Week 12
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
次要结局
- Total EoS (Eosinophil) Counts(Week 1)
- Score on Voice Handicap Index 10 (VHI-10)(Week 12)
- Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)(Week 12)
- Total IgE (Immunoglobulin E) Levels(Week 1)
- Score on Leicester Cough Questionnaire (LCQ)(Week 12)
- Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)(Week 12)
- Levels of Fractional Exhaled Nitric Oxide (FeNO)(Week 12)
- Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)(Week 12)