Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

January 12, 2021 updated by: NYU Langone Health

Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Fluticasone propionate 230mcg for 3 Months
Other Names:
  • Advair HFA
Drug: Salmeterol 21mcg for 3 Months
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Oscillation Technique (FOT) Measures
Time Frame: Week 12
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Week 12
Spirometry Measures
Time Frame: 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
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Time Frame: Week 12
To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
Week 12
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
Time Frame: Week 12
measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Week 12
Total IgE (Immunoglobulin E) Levels
Time Frame: Week 1
IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Week 1
Total EoS (Eosinophil) Counts
Time Frame: Week 1
EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Week 1
Levels of Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Week 12
Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.
Week 12
Score on Voice Handicap Index 10 (VHI-10)
Time Frame: Week 12
Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score > 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.
Week 12
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
Time Frame: Week 12
For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).
Week 12
Score on Leicester Cough Questionnaire (LCQ)
Time Frame: Week 12
For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

  • Principal Investigator: Joan Reibman, M.D, NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2014

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 26, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-00448
  • 1U01OH010404-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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