Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

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.

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.)