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

9 juli 2017 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Förväntat)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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%

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The difference of CAT scores between patients with airway disease and those without airway disease.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seoul National University Hospital

Utredare

  • Huvudutredare: 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 juni 2017

Primärt slutförande (Förväntat)

28 februari 2020

Avslutad studie (Förväntat)

28 februari 2020

Studieregistreringsdatum

Först inskickad

18 juni 2017

Först inskickad som uppfyllde QC-kriterierna

9 juli 2017

Första postat (Faktisk)

12 juli 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ILD Asthma

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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