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

9. juli 2017 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The difference of CAT scores between patients with airway disease and those without airway disease.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Efterforskere

  • Ledende efterforsker: 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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juni 2017

Primær færdiggørelse (Forventet)

28. februar 2020

Studieafslutning (Forventet)

28. februar 2020

Datoer for studieregistrering

Først indsendt

18. juni 2017

Først indsendt, der opfyldte QC-kriterier

9. juli 2017

Først opslået (Faktiske)

12. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ILD Asthma

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