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- Klinische proef NCT03215147
Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van
- Werving
- Seoul National University Hospital
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Contact:
- Choi Sun Mi
- Telefoonnummer: 02-2072-4915
- E-mail: sunmich81@gmail.com
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Contact:
- PARK HEEMOON
- E-mail: coramdeo33@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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%
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Tijdsspanne: Through study completion, an average of 2 year
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Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
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Through study completion, an average of 2 year
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Number of participants who have COPD combined with idiopathic pulmonary fibrosis
Tijdsspanne: Through study completion, an average of 2 year
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Confirmation of COPD : pulmonary function test with bronchodilator response
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Through study completion, an average of 2 year
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Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
Tijdsspanne: Through study completion, an average of 2 year
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Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
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Through study completion, an average of 2 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The difference of CAT scores between patients with airway disease and those without airway disease.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Quality of life : COPD assessment test(CAT)
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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.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Quality of life : St George's Respiratory Questionnaire(SGRQ)
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baseline and after treating the airway disease for 6~8 weeks
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The difference of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : mMRC
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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.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : 6 minute walking test(6MWT)
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baseline and after treating the airway disease for 6~8 weeks
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The difference of EQ-5D-VAS scores to assess symptom severity between patients with airway disease and those without airway disease.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : EQ-5D-VAS
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baseline and after treating the airway disease for 6~8 weeks
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The difference of CQLQ scores to assess symptom severity between patients with airway disease and those without airway disease.
Tijdsspanne: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
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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
Tijdsspanne: After treating the airway disease for 6~8 weeks
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Quality of life : COPD assessment test(CAT)
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After treating the airway disease for 6~8 weeks
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Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway disease
Tijdsspanne: 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
Tijdsspanne: After treating the airway disease for 6~8 weeks
|
Symptom severity : mMRC
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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
Tijdsspanne: 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
Tijdsspanne: After treating the airway disease for 6~8 weeks
|
Symptom severity : EQ-5D-VAS
|
After treating the airway disease for 6~8 weeks
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Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway disease
Tijdsspanne: After treating the airway disease for 6~8 weeks
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Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
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After treating the airway disease for 6~8 weeks
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: 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
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ILD Asthma
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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