Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
12 janvier 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10016
- New York University School of Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Autres noms:
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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Forced Oscillation Technique (FOT) Measures
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Joan Reibman, M.D, NYU School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 avril 2014
Achèvement primaire (Réel)
17 mai 2017
Achèvement de l'étude (Réel)
17 mai 2017
Dates d'inscription aux études
Première soumission
18 décembre 2013
Première soumission répondant aux critères de contrôle qualité
26 décembre 2013
Première publication (Estimation)
31 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 février 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Signes et symptômes respiratoires
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agonistes adrénergiques
- Agents dermatologiques
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Agents anti-allergiques
- Agonistes des récepteurs bêta-2 adrénergiques
- Bêta-agonistes adrénergiques
- Sympathomimétiques
- Fluticasone
- Xhance
- Xinafoate de salmétérol
- Association médicamenteuse fluticasone-salmétérol
Autres numéros d'identification d'étude
- 13-00448
- 1U01OH010404-01A1 (Subvention/contrat des NIH des États-Unis)
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