Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
9 de julho de 2017 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Seoul, Republica da Coréia
- Recrutamento
- Seoul National University Hospital
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Contato:
- Choi Sun Mi
- Número de telefone: 02-2072-4915
- E-mail: sunmich81@gmail.com
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Contato:
- PARK HEEMOON
- E-mail: coramdeo33@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
Descrição
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%
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The difference of CAT scores between patients with airway disease and those without airway disease.
Prazo: 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
|
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The difference of SGRQ scores to assess quality of life between patients with airway disease and those without airway disease.
Prazo: 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.
Prazo: 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
|
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The difference of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease.
Prazo: 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.
Prazo: 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.
Prazo: 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
|
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Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de junho de 2017
Conclusão Primária (Antecipado)
28 de fevereiro de 2020
Conclusão do estudo (Antecipado)
28 de fevereiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
18 de junho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de julho de 2017
Primeira postagem (Real)
12 de julho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de julho de 2017
Última verificação
1 de julho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ILD Asthma
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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