Remodelling of the Lower Airways in Chronic Cough
Does Chronic Cough Lead to Injury and Remodelling of the Lower Airways?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cough is a physiological defensive reflex which decreases the risk of aspiration to the lower airways and allows to remove sputum and excessive mucus from the airways. However, in some cases, persisting intensive cough may result in many complications and decrease in patients' quality of life. Damage of the airway epithelium due to infection, chemical or mechanical injury leads to an increase in the frequency or intensity of cough.
The aim of the study is to assess if chronic cough leads to damage and remodelling of the airways. We plan to analyse bronchial injury and remodelling in patients with refractory chronic cough lasting longer than 12 months. Assessment of injury mediators will be performed in blood and BALF. Remodelling will be analysed based on chest CT scan and pathologic specimens. Injury of epithelium will be assessed in pathologic specimens of bronchial biopsy. The relationship between the duration, severity of chronic cough and bronchial inflammation, damage, remodelling will be analysed.
Patients with refractory chronic cough and clinical indications for bronchoscopy (such as: productive cough, mucus plugs or bronchiectasis in chest CT, suspected extensive dynamic airway collapse (EDAC), assessment of eosinophilic airway inflammation when induced sputum could not be obtained, or any suspicion or high risk of malignancy) will be invited to take part in the study.
We plan to enroll 40 non-smoking patients with chronic cough lasting longer than 12 months, who had already been unsuccessfully treated because of cough. Thorough diagnostics of cough reason will be performed. Besides parameters of bronchial inflammation, remodelling and injury will be analysed in serum and BALF. Injury and remodelling will also be assessed in bronchial biopsy and in chest CT.
The results of the study will assess if refractory chronic cough is associated with any type of airway inflammation, bronchial injury or remodeling.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marta Dąbrowska, MD, PhD
- Número de teléfono: +48 501157765
- Correo electrónico: mdabrowska@mp.pl
Copia de seguridad de contactos de estudio
- Nombre: Karolina Klimowicz, MD
- Número de teléfono: +48 507045417
- Correo electrónico: mdabrowska@mp.pl
Ubicaciones de estudio
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Warsaw, Polonia, 02-091
- Reclutamiento
- Medical University of Warsaw
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Contacto:
- Karolina Klimowicz, PhD candidate
- Número de teléfono: +48507045417
- Correo electrónico: karolinaakrakowiak@gmail.com
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Warsaw, Polonia, 02-097
- Reclutamiento
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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Contacto:
- Marta Dąbrowska
- Número de teléfono: 501157765
- Correo electrónico: mdabrowska@mp.pl
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 02-097
- Reclutamiento
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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Contacto:
- Marta Dąbrowska, MD, PhD
- Número de teléfono: +48 501157765
- Correo electrónico: mdabrowska@mp.pl
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Contacto:
- Karolina Klimowicz, MD
- Número de teléfono: +48 507045417
- Correo electrónico: karolinaakrakowiak@gmail.com
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Investigador principal:
- Marta Dąbrowska, MD, PhD
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Sub-Investigador:
- Karolina Klimowicz, MD
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Warsaw
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Warsaw, Warsaw, Polonia, 02-097
- Reclutamiento
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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Contacto:
- Karolina Klimowicz, MD
- Número de teléfono: +48 507045417
- Correo electrónico: mdabrowska@mp.pl
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Investigador principal:
- Marta Dąbrowska, MD, PhD
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Contacto:
- Marta Dąbrowska
- Número de teléfono: +48 501157765
- Correo electrónico: mdabrowska@mp.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion criteria for the study group:
- age between 18 and 75 years,
- chronic cough of at least one year duration, with no previous treatment (at least 2 previous unsuccessful attempts at pharmacological treatment of cough)
- negative history of smoking (at least 6 months of abstinence),
- negative history of treatment with angiotensin-converting enzyme inhibitors (ACEI),
- normal chest radiograph or with changes not relevant to cough formation,
- no respiratory tract infections in the past 6 weeks,
- written consent from the patient to participate in the study.
Exclusion Criteria:
- patients less than 18 and more than 75 years of age,
- cough lasting less than 12 months,
- active smoking or abstinence period of less than 6 months,
- respiratory tract infection 6 weeks prior to inclusion or at the time of study conduct - retry inclusion after 6 weeks,
- cancer or interstitial lung disease,
- contraindications to functional testing, sputum induction or bronchoscopy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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40 patients with refractory chronic cough lasting more than 6 months.
Patients were eligible for inclusion if they: were 18-75 years old; had chronic cough lasting more than 12 months unresponsive to previous treatment presented with a normal or near normal chest radiograph or only abnormalities irrelevant to cough; and had clinical indications for bronchoscopy |
Assessment of airway remodeling features on chest CT in patients with chronic cough. Evaluation of airway injury and remodeling based on biological specimens obtained from the lower airways during bronchoscopy.Bronchoscopy is performed if clinically indicated.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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assessment of the severity of epithelial damage and inflammation in the bronchial biopsy
Periodo de tiempo: baseline
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Bronchial biopsy will be analysed for airway inflammation and remodeling features such as proportion of epithelial shedding basement membrane thickening, infiltration of inflammatory cells and subbasement membrane (SBM) thickening.
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baseline
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assessment of airway inflammation and remodeling in the airways in chest CT
Periodo de tiempo: baseline
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The CT scans will be evaluated for the presence, extent, and severity of bronchial wall thickening, bronchiectasis, mucus plugs, centrilobular abnormalities, air trapping or mosaic attenuation.
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baseline
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Assessment of biomarkers of inflammation in serum and BALF
Periodo de tiempo: baseline
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Assessment of cellular composition and inflammatory biomarkers in serum and BALF ( IL-2, IL4, IL-5, IL-8, PGE2, periostin, TSLP),
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baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rafał Krenke, MD, PhD, Prof, Department of Internal Medicine, Pulmonary Diseases and Allergy, Warsaw Medical University
Publicaciones y enlaces útiles
Publicaciones Generales
- Gibson P, Wang G, McGarvey L, Vertigan AE, Altman KW, Birring SS; CHEST Expert Cough Panel. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016 Jan;149(1):27-44. doi: 10.1378/chest.15-1496. Epub 2016 Jan 6.
- Chung KF, McGarvey L, Song WJ, Chang AB, Lai K, Canning BJ, Birring SS, Smith JA, Mazzone SB. Cough hypersensitivity and chronic cough. Nat Rev Dis Primers. 2022 Jun 30;8(1):45. doi: 10.1038/s41572-022-00370-w.
- Macedo P, Zhang Q, Saito J, Liang Z, Ffolkes L, Nicholson AG, Chung KF. Analysis of bronchial biopsies in chronic cough. Respir Med. 2017 Jun;127:40-44. doi: 10.1016/j.rmed.2017.04.001. Epub 2017 Apr 4.
- Dabrowska M, Grabczak EM, Arcimowicz M, Domeracka-Kolodziej A, Domagala-Kulawik J, Krenke R, Maskey-Warzechowska M, Tarchalska B, Chazan R. Causes of Chronic Cough in Non-smoking Patients. Adv Exp Med Biol. 2015;873:25-33. doi: 10.1007/5584_2015_153.
- Irwin RS, French CL, Chang AB, Altman KW; CHEST Expert Cough Panel*. Classification of Cough as a Symptom in Adults and Management Algorithms: CHEST Guideline and Expert Panel Report. Chest. 2018 Jan;153(1):196-209. doi: 10.1016/j.chest.2017.10.016. Epub 2017 Nov 10.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Signos y Síntomas Respiratorios
- Tos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Tos crónica
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos mínimamente invasivos
- Técnicas de diagnóstico, quirúrgico
- Endoscopia
- Técnicas de diagnóstico, sistema respiratorio
- Procedimientos quirúrgicos torácicos
- Procedimientos quirúrgicos pulmonares
- Broncoscopia
Otros números de identificación del estudio
- Remodelling in CC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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