Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
9 juillet 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Observationnel
Inscription (Anticipé)
100
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.
Coordonnées de l'étude
- Nom: Choi Sun Mi
- Numéro de téléphone: 02-2072-4915
- E-mail: sunmich81@gmail.com
Sauvegarde des contacts de l'étude
- Nom: PARK HEEMOON
- E-mail: coramdeo33@gmail.com
Lieux d'étude
-
-
-
Seoul, Corée, République de
- Recrutement
- Seoul National University Hospital
-
Contact:
- Choi Sun Mi
- Numéro de téléphone: 02-2072-4915
- E-mail: sunmich81@gmail.com
-
Contact:
- PARK HEEMOON
- E-mail: coramdeo33@gmail.com
-
-
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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
La description
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 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
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The difference of CAT scores between patients with airway disease and those without airway disease.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur 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
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)
7 juin 2017
Achèvement primaire (Anticipé)
28 février 2020
Achèvement de l'étude (Anticipé)
28 février 2020
Dates d'inscription aux études
Première soumission
18 juin 2017
Première soumission répondant aux critères de contrôle qualité
9 juillet 2017
Première publication (Réel)
12 juillet 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juillet 2017
Dernière vérification
1 juillet 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ILD Asthma
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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