Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
12 januari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10016
- New York University School of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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Andere namen:
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Ander: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Forced Oscillation Technique (FOT) Measures
Tijdsspanne: Week 12
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Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
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Week 12
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Spirometry Measures
Tijdsspanne: Week 12
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Tijdsspanne: Week 12
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To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
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Week 12
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Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
Tijdsspanne: Week 12
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measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
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Week 12
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Total IgE (Immunoglobulin E) Levels
Tijdsspanne: Week 1
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IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
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Week 1
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Total EoS (Eosinophil) Counts
Tijdsspanne: Week 1
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EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
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Week 1
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Levels of Fractional Exhaled Nitric Oxide (FeNO)
Tijdsspanne: Week 12
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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.
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Week 12
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Score on Voice Handicap Index 10 (VHI-10)
Tijdsspanne: Week 12
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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.
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Week 12
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Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
Tijdsspanne: Week 12
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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).
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Week 12
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Score on Leicester Cough Questionnaire (LCQ)
Tijdsspanne: Week 12
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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.
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Week 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Joan Reibman, M.D, NYU School of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
9 april 2014
Primaire voltooiing (Werkelijk)
17 mei 2017
Studie voltooiing (Werkelijk)
17 mei 2017
Studieregistratiedata
Eerst ingediend
18 december 2013
Eerst ingediend dat voldeed aan de QC-criteria
26 december 2013
Eerst geplaatst (Schatting)
31 december 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 februari 2021
Laatste update ingediend die voldeed aan QC-criteria
12 januari 2021
Laatst geverifieerd
1 januari 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Longziekten
- Tekenen en symptomen, ademhaling
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Adrenerge agonisten
- Dermatologische middelen
- Bronchusverwijdende middelen
- Anti-astmatische middelen
- Agenten van het ademhalingssysteem
- Anti-allergische middelen
- Adrenerge bèta-2-receptoragonisten
- Adrenerge beta-agonisten
- Sympathicomimetica
- Fluticason
- Xhance
- Salmeterol Xinafoaat
- Fluticason-Salmeterol Geneesmiddelencombinatie
Andere studie-ID-nummers
- 13-00448
- 1U01OH010404-01A1 (Subsidie/contract van de Amerikaanse NIH)
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