Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by New York University School of Medicine
Sponsor:
Collaborator:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02024204
First received: December 18, 2013
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Lung Diseases
Medication Compliance
Drug: Fluticasone propionate 230mcg for 3 Months
Drug: Current Treatment or no treatment
Drug: Salmeterol 21mcg for 3 Months

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Change in measures of airflow and lung volumes by spirometry and small airway dysfunction by impulse oscillometry and association with uncontrolled lower respiratory symptoms [ Time Frame: Week 1, Week 12 ] [ Designated as safety issue: No ]
    To test whether measurements of airflow and lung volume (spirometry) and of small airway dysfunction (impulse oscillometry) are associated with uncontrolled lower respiratory symptoms

  • Change in lower respiratory symptom control status [ Time Frame: Week 1, Week 12 ] [ Designated as safety issue: No ]
    To test whether a 3-month treatment with combined high-dose inhaled corticosteroids and long-acting bronchodilators results in improved lower respiratory symptoms, assessed by the Asthma Control Test and the Asthma Symptom Utility Index


Secondary Outcome Measures:
  • Bronchial Hyperresponsiveness [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    To test whether bronchial hyperresponsiveness (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms

  • Inflammatory Markers Associated with Airway Disease (CRP, RAST, Eos and Periostin) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    To compare levels of circulating biomarkers associated with a Th2 inflammatory response (total and allergen-specific IgE, circulating eosinophils, C-reactive protein, serum periostin) in patients with uncontrolled lower respiratory symptoms and controlled lower respiratory symptoms. The total amount of blood drawn will be 30 mL.

  • Gastroesophageal reflux symptoms [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    To compare rates of gastroesophageal reflux symptoms, assessed by questionnaire, in patients with uncontrolled lower respiratory symptoms and controlled lower respiratory symptoms

  • Chronic rhinosinusitis symptoms [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    To compare rates of chronic rhinosinusitis symptoms, assessed by questionnaire, in patients with uncontrolled lower respiratory symptoms and controlled lower respiratory symptoms

  • Paradoxical vocal cord motion (PVCM) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    To compare rates of paradoxical vocal cord motion, assessed by videolaryngostroboscopy with provocation, in patients with uncontrolled lower respiratory symptoms and controlled lower respiratory symptoms.

  • Changes in levels of fractional exhaled nitric oxide (FeNO) [ Time Frame: Week 1, Week 12 ] [ Designated as safety issue: No ]
    To compare levels of an exhaled marker of inflammation (Fractional exhaled nitric oxide; FeNO) in patients with uncontrolled lower respiratory symptoms and controlled lower respiratory symptoms at baseline and at the end of the 3 month course of treatment.

  • Dyspnea and Functional status [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    To assess dyspnea and functional status using the 6 minute walk test between subjects with uncontrolled and controlled lower respiratory symptoms at the end of the 3 month course of treatment.


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Visit 1 Uncontrolled LRS
Patients who have uncontrolled LRS (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.
Drug: Fluticasone propionate 230mcg for 3 Months
Other Name: Advair HFA
Drug: Salmeterol 21mcg for 3 Months
Visit 1 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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024204

Contacts
Contact: Samantha Kalish 212-263-6479 samantha.kalish@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Samantha Kalish    646-501-4137    samantha.kalish@nyumc.org   
Principal Investigator: Joan Reibman, M.D.         
Sponsors and Collaborators
New York University School of Medicine
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
Principal Investigator: Joan Reibman, M.D NYU School of Medicine
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02024204     History of Changes
Other Study ID Numbers: 13-00448  1U01OH010404-01A1 
Study First Received: December 18, 2013
Last Updated: March 29, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Environmental Exposure
World Trade Center Disaster
Respiratory Physiology
Inflammation
Gastrointestinal Diseases
Sinus Symptoms
PTSD
Anxiety
Depression
Hypersensitivity
Spirometry
Oscillometry

Additional relevant MeSH terms:
Lung Diseases
Signs and Symptoms, Respiratory
Respiratory Tract Diseases
Signs and Symptoms
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016