Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
9. Juli 2017 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
100
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Seoul, Korea, Republik von
- Rekrutierung
- Seoul National University Hospital
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Kontakt:
- Choi Sun Mi
- Telefonnummer: 02-2072-4915
- E-Mail: sunmich81@gmail.com
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Kontakt:
- PARK HEEMOON
- E-Mail: coramdeo33@gmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
Beschreibung
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%
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The difference of CAT scores between patients with airway disease and those without airway disease.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: After treating the airway disease for 6~8 weeks
|
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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
7. Juni 2017
Primärer Abschluss (Voraussichtlich)
28. Februar 2020
Studienabschluss (Voraussichtlich)
28. Februar 2020
Studienanmeldedaten
Zuerst eingereicht
18. Juni 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juli 2017
Zuerst gepostet (Tatsächlich)
12. Juli 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Juli 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juli 2017
Zuletzt verifiziert
1. Juli 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ILD Asthma
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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