Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
12. januar 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10016
- New York University School of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Andre navn:
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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Forced Oscillation Technique (FOT) Measures
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joan Reibman, M.D, NYU School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. april 2014
Primær fullføring (Faktiske)
17. mai 2017
Studiet fullført (Faktiske)
17. mai 2017
Datoer for studieregistrering
Først innsendt
18. desember 2013
Først innsendt som oppfylte QC-kriteriene
26. desember 2013
Først lagt ut (Anslag)
31. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Lungesykdommer
- Tegn og symptomer, luftveier
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Adrenerge agonister
- Dermatologiske midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Anti-allergiske midler
- Adrenerge beta-2-reseptoragonister
- Adrenerge beta-agonister
- Sympatomimetikk
- Flutikason
- Xhance
- Salmeterol Xinafoate
- Flutikason-salmeterol medikamentkombinasjon
Andre studie-ID-numre
- 13-00448
- 1U01OH010404-01A1 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .