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Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis

9 de julio de 2017 actualizado por: Sun Mi Choi, Seoul National University Hospital
The investigators assess the prevalence of airway disease associated with idiopathic pulmonary fibrosis in Korea, and evaluate the effect of these airway diseases on the symptoms and quality of life of patients with idiopathic pulmonary fibrosis.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Idiopathic pulmonary fibrosis (IPF) is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and limited to the lungs. It is characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis.

The main symptoms of patients with IPF are dyspnea on exertion and a persistent dry cough or mildly productive cough.

In many IPF patients, cough is often the first symptom, preceding dyspnea on exertion sometimes by years. It affects upwards of 70-85% of patients with IPF.

Chronic obstructive pulmonary disease (prevalence rate 4-18%) and asthma (prevalence rate 5.9-9.9%) are the airway disease whose main symptoms are also dyspnea and cough.

To date, the effect of airway disease has not been well studied in patients with idiopathic pulmonary fibrosis, and the prevalence is unknown in Korea.

Unlike idiopathic pulmonary fibrosis, airway disease is a treatable, modifiable disease, so treatment of these diseases may improve QOL in IPF patients.

Therefore, this study's purpose is A. Identify the prevalence of airway disease in IPF patients B. Identify differences in QOL and symptoms according to presence of airway disease C. Identify the symptomatic improvement after active treatment for the airway diseases

Tipo de estudio

De observación

Inscripción (Anticipado)

100

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Choi Sun Mi
  • Número de teléfono: 02-2072-4915
  • Correo electrónico: sunmich81@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward

Descripción

Inclusion Criteria:

  • IPF patients

Exclusion Criteria:

  • Patients on systemic steroid
  • Patients with acute exacerbation within the last 6 months
  • PFT+BDR, MBPT contra-indication
  • SpO2 < 90%

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Periodo de tiempo: Through study completion, an average of 2 year
Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
Through study completion, an average of 2 year
Number of participants who have COPD combined with idiopathic pulmonary fibrosis
Periodo de tiempo: Through study completion, an average of 2 year
Confirmation of COPD : pulmonary function test with bronchodilator response
Through study completion, an average of 2 year
Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
Periodo de tiempo: Through study completion, an average of 2 year
Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
Through study completion, an average of 2 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The difference of CAT scores between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Quality of life : COPD assessment test(CAT)
baseline and after treating the airway disease for 6~8 weeks
The difference of SGRQ scores to assess quality of life between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Quality of life : St George's Respiratory Questionnaire(SGRQ)
baseline and after treating the airway disease for 6~8 weeks
The difference of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Symptom severity : mMRC
baseline and after treating the airway disease for 6~8 weeks
The difference of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Symptom severity : 6 minute walking test(6MWT)
baseline and after treating the airway disease for 6~8 weeks
The difference of EQ-5D-VAS scores to assess symptom severity between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Symptom severity : EQ-5D-VAS
baseline and after treating the airway disease for 6~8 weeks
The difference of CQLQ scores to assess symptom severity between patients with airway disease and those without airway disease.
Periodo de tiempo: baseline and after treating the airway disease for 6~8 weeks
Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
baseline and after treating the airway disease for 6~8 weeks
Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Quality of life : COPD assessment test(CAT)
After treating the airway disease for 6~8 weeks
Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Quality of life : St George's Respiratory Questionnaire(SGRQ)
After treating the airway disease for 6~8 weeks
Checking the improvement of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Symptom severity : mMRC
After treating the airway disease for 6~8 weeks
Checking the improvement of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Symptom severity : 6 minute walking test(6MWT)
After treating the airway disease for 6~8 weeks
Checking the improvement of EQ-5D-VAS score to assess symptom severity between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Symptom severity : EQ-5D-VAS
After treating the airway disease for 6~8 weeks
Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway disease
Periodo de tiempo: After treating the airway disease for 6~8 weeks
Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
After treating the airway disease for 6~8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Seoul National University Hospital

Investigadores

  • Investigador principal: Choi Sun Mi, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung institute, Seoul National University College of Medicine, Seoul, Korea

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de junio de 2017

Finalización primaria (Anticipado)

28 de febrero de 2020

Finalización del estudio (Anticipado)

28 de febrero de 2020

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2017

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2017

Publicado por primera vez (Actual)

12 de julio de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

9 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ILD Asthma

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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