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Completed

NCT Number: NCT02024204

Uncontrolled Lower Respiratory Symptoms in the WTC 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.

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Key information

Conditions

Lung Diseases Anxiety Disorders Behavior Behavioral Symptoms Depression Digestive System Diseases Gastrointestinal Diseases Health Behavior Hypersensitivity Immune System Diseases Inflammation Medication Adherence Medication Compliance Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Treatment Adherence and Compliance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Fluticasone propionate 230mcg for 3 Months

Drug

Other names: Advair HFA

Current Treatment or no treatment

Drug

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.

Salmeterol 21mcg for 3 Months

Drug

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Total EoS (Eosinophil) Counts

    Time frame: Week 1

    EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Official study title

Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2013
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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