Clinical trial NCT03215147: Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
Official title: Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Pulmonary Fibrosis
Airway Disease
Keywords: Idiopathic Pulmonary Fibrosis
Airway Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward

Brief 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.

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

Eligibility criteria: 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%

Primary outcomes:
measure: Number of participants who have asthma combined with idiopathic pulmonary fibrosis
timeFrame: Through study completion, an average of 2 year
measure: Number of participants who have COPD combined with idiopathic pulmonary fibrosis
timeFrame: Through study completion, an average of 2 year
measure: Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: The difference of CAT scores between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: The difference of SGRQ scores to assess quality of life between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: The difference of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: The difference of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: The difference of EQ-5D-VAS scores to assess symptom severity between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: The difference of CQLQ scores to assess symptom severity between patients with airway disease and those without airway disease.
timeFrame: baseline and after treating the airway disease for 6~8 weeks
measure: Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
measure: Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
measure: Checking the improvement of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
measure: Checking the improvement of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
measure: Checking the improvement of EQ-5D-VAS score to assess symptom severity between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
measure: Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway disease
timeFrame: After treating the airway disease for 6~8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung institute, Seoul National University College of Medicine, Seoul, Korea
name: Choi Sun Mi
role: PRINCIPAL_INVESTIGATOR
References: