Clinical trial NCT02024204: Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Official title: Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2013-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.)

Primary outcomes:
measure: Forced Oscillation Technique (FOT) Measures
timeFrame: Week 12
measure: Spirometry Measures
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
timeFrame: Week 12
measure: Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
timeFrame: Week 12
measure: Total IgE (Immunoglobulin E) Levels
timeFrame: Week 1
measure: Total EoS (Eosinophil) Counts
timeFrame: Week 1
measure: Levels of Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Week 12
measure: Score on Voice Handicap Index 10 (VHI-10)
timeFrame: Week 12
measure: Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
timeFrame: Week 12
measure: Score on Leicester Cough Questionnaire (LCQ)
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Joan Reibman, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.