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Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Diseases; Medication Compliance

Intervention: Fluticasone propionate 230mcg/salmeterol 21mcg (Drug); Medication Adherence Counseling (Behavioral)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Joan Reibman, M.D, Principal Investigator, Affiliation: NYU School of Medicine

Summary

Our hypothesis is that World Trade Center Environmental Health Center patients with uncontrolled lower respiratory symptoms,that include cough, dyspnea, wheeze and chest tightness, have increased rates of abnormal airway physiology, airway inflammation and co-morbid conditions despite medical therapy. Identifying mechanisms for uncontrolled lower respiratory symptoms (LRS) is imperative to guide therapy with the important potential to reduce secondary adverse health outcomes. To test this hypothesis, we 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.

Clinical Details

Official title: Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in measures of airflow and lung volumes by spirometry and small airway dysfunction by impulse oscillometry and association with uncontrolled lower respiratory symptoms

Change in lower respiratory symptom control status

Secondary outcome:

Bronchial Hyperresponsiveness

Inflammatory Markers Associated with Airway Disease (CRP, RAST, Eos and Periostin)

Gastroesophageal reflux symptoms

Chronic rhinosinusitis symptoms

Paradoxical vocal cord motion (PVCM)

Changes in levels of fractional exhaled nitric oxide (FeNO)

Dyspnea and Functional status

Detailed description: Exposure to the dust and fumes of the World Trade Center (WTC) disaster resulted in adverse health including upper and lower respiratory symptoms in responders and community members. The WTC Environmental Health Center (WTC EHC), initiated in 2005, was the first and remains the only treatment program that targets community members, now called "Survivors," including local residents, local workers and clean-up workers with WTC dust and fume exposures. Lower respiratory symptoms are prevalent in patients in the WTC EHC. Most patients with these symptoms in the "Responder" and "Survivor" programs are diagnosed with asthma and this diagnosis has guided therapy. Although spirometry is often normal, diagnosis has been supported by studies showing bronchial hyperresponsiveness (BHR) in some, and distal or small airways disease measured with impulse oscillometry (IOS). As a result, the WTC EHC program has used a treatment algorithm based on guidelines for asthma from the National Institutes of Health. These guidelines focus on the use of "controller" therapy, which includes inhaled corticosteroids (ICS) and long acting bronchodilators (LABA) for persistent symptoms. Despite this approach, eleven years after the destruction of the WTC towers, many patients in the WTC EHC report incomplete clinical response with continued lower respiratory symptoms. In fact, patients with continued uncontrolled lower respiratory symptoms (LRS) remain on treatment with long-term high dose ICS often with additional LABA use, rendering them at risk for adverse health effects of long term ICS treatment. The persistence of symptoms, despite therapeutic interventions, necessitates a reevaluation and a search for causes of persistent symptoms. Possibilities include incomplete adherence with medical regimens, continuing airways disease (BHR or small airways disease) with persistent lung inflammation, or the presence of co-morbid conditions. .

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.)

Locations and Contacts

New York University School of Medicine, New York, New York 10016, United States
Additional Information

Related publications:

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330.

Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b.

Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC.

Starting date: January 2014
Last updated: March 5, 2015

Page last updated: August 23, 2015

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