N/A
N=60
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Lung Diseases · Medication Compliance
Bottom Line
View on ClinicalTrials.gov: NCT02024204 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Forced Oscillation Technique (FOT) Measures — 4.4; 3.7; 1.0; 0.6 resonant frequency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluticasone propionate 230mcg for 3 Months (Drug); Current Treatment or no treatment (Drug); Salmeterol 21mcg for 3 Months (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Oscillation Technique (FOT) Measures |
4.4; 3.7; 1.0; 0.6; 4.1; 4.0 | — |
| PRIMARY Spirometry Measures |
78.5; 81.2; 78.3; 77.7 | — |
| SECONDARY Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR) |
18; 6 | — |
| SECONDARY Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM) |
21; 6 | — |
| SECONDARY Total IgE (Immunoglobulin E) Levels |
41; 31 | — |
| SECONDARY Total EoS (Eosinophil) Counts |
.10; .10 | — |
| SECONDARY Levels of Fractional Exhaled Nitric Oxide (FeNO) |
17.8; 13 | — |
| SECONDARY Score on Voice Handicap Index 10 (VHI-10) |
7; 1 | — |
| SECONDARY Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD) |
35; 26 | — |
| SECONDARY Score on Leicester Cough Questionnaire (LCQ) |
12; 15.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years and 2 times per week)
- Pre-bronchodilator forced expiratory volume in one second (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.)
Data sourced from ClinicalTrials.gov (NCT02024204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.