Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

NCT02024204 | Completed Results

• 2 other identifiers: 13-004481U01OH010404-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Diseases; Medication Compliance

Keywords

World Trade Center Disaster; Environmental Exposure; Respiratory Physiology; Inflammation; Gastrointestinal Diseases; Sinus Symptoms; PTSD; Anxiety; Depression; Hypersensitivity; Spirometry; Oscillometry

Outcome Measures

Primary Outcomes (2)

• Forced Oscillation Technique (FOT) Measures

  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

  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 Outcomes (8)

• Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)

  Week 12

• Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)

  Week 12

• Total IgE (Immunoglobulin E) Levels

  Week 1

• Total EoS (Eosinophil) Counts

  Week 1

• Levels of Fractional Exhaled Nitric Oxide (FeNO)

  Week 12

Study Arms (2)

Uncontrolled LRS

ACTIVE COMPARATOR

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; Drug: Salmeterol 21mcg for 3 Months

Controlled LRS

OTHER

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

Interventions

Fluticasone propionate 230mcg for 3 Months DRUG

Also known as: Advair HFA

Uncontrolled LRS

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.

Controlled LRS

Salmeterol 21mcg for 3 Months DRUG

Uncontrolled LRS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• 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.

  PMID: 19365288 BACKGROUND

• 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.

  PMID: 21642248 BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Medication Adherence; Inflammation; Gastrointestinal Diseases; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; Hypersensitivity

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Joan Reibman, MD
• Organization: NYU Langone

joan.reibman@nyumc.org

212-263-6479

Study Officials

• Joan Reibman, M.D

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 31, 2013
• Study Start: April 9, 2014
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)