Idiopathic Pulmonary FibrosisNCT03215147
Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis and Airway Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Airway Disease
- What is being tested?
- Confirmation of Airway Disease combined with IPF
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2017to 28 Feb 2020
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
Who may be able to join
- IPF patients
Who cannot join
- Patients on systemic steroid
- Patients with acute exacerbation within the last 6 months
- PFT+BDR, MBPT contra-indication
- SpO2 < 90%
Trial locations and contacts
1 site in 1 country.
PARK HEEMOON contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Choi Sun Mi, 02-2072-4915, sunmich81@gmail.com
PARK HEEMOON, coramdeo33@gmail.com
About this study
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.
Read the detailed description
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
- Conditions
- Idiopathic Pulmonary Fibrosis, Airway Disease
- Being tested
- Confirmation of Airway Disease combined with IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, Airway Disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confirmation of Airway Disease combined with IPFDiagnostic test
To confirm the airway disease combined with IPF, PFT+BDR+DLCO, MBPT, Induced sputum exam, MAST, Total IgE, serum Eosinophil count, FENO will be done at the time of registration and 6~8 weeks later.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
Measured: Through study completion, an average of 2 year
Number of participants who have COPD combined with idiopathic pulmonary fibrosis
Confirmation of COPD : pulmonary function test with bronchodilator response
Measured: Through study completion, an average of 2 year
Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
Measured: Through study completion, an average of 2 year
Secondary outcomes (12)
The difference of CAT scores between patients with airway disease and those without airway disease.
Quality of life : COPD assessment test(CAT)
Measured: 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.
Quality of life : St George's Respiratory Questionnaire(SGRQ)
Measured: 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.
Symptom severity : mMRC
Measured: 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.
Symptom severity : 6 minute walking test(6MWT)
Measured: 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.
Symptom severity : EQ-5D-VAS
Measured: 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.
Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
Measured: 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
Quality of life : COPD assessment test(CAT)
Measured: 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
Quality of life : St George's Respiratory Questionnaire(SGRQ)
Measured: 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
Symptom severity : mMRC
Measured: 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
Symptom severity : 6 minute walking test(6MWT)
Measured: 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
Symptom severity : EQ-5D-VAS
Measured: 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
Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
Measured: After treating the airway disease for 6~8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start7 Jun 2017
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Mi Choi, Seoul National University Hospital
- Investigators
- Choi Sun Mi, Principal investigator, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung institute, Seoul National University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215147
- Sponsor's protocol ID
- ILD Asthma
- Status last verified
- Jul 2017
- First submitted
- 18 Jun 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03215147
- Acronym / sponsor ID
- ILD Asthma
- Conditions
- Idiopathic Pulmonary Fibrosis, Airway Disease
- Keywords
- Idiopathic Pulmonary Fibrosis, Airway Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
Key inclusion criteria (1 listed)
- IPF patients
Key exclusion criteria (4 listed)
- Patients on systemic steroid
- Patients with acute exacerbation within the last 6 months
- PFT+BDR, MBPT contra-indication
- SpO2 < 90%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confirmation of Airway Disease combined with IPFTo confirm the airway disease combined with IPF, PFT+BDR+DLCO, MBPT, Induced sputum exam, MAST, Total IgE, serum Eosinophil count, FENO will be done at the time of registration and 6~8 weeks later. | Diagnostic test | – |
Primary outcome
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Time frame: Through study completion, an average of 2 year
Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
Number of participants who have COPD combined with idiopathic pulmonary fibrosis
Time frame: Through study completion, an average of 2 year
Confirmation of COPD : pulmonary function test with bronchodilator response
Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
Time frame: Through study completion, an average of 2 year
Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
12 secondary outcomes
The difference of CAT scores between patients with airway disease and those without airway disease.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After treating the airway disease for 6~8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PARK HEEMOON contact
Choi Sun Mi principal investigator
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung institute, Seoul National University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Airway Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choi Sun Mi (02-2072-4915, sunmich81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have asthma combined with idiopathic pulmonary fibrosis (time frame: Through study completion, an average of 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.