Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL and disease progression has only been studied sparsely. Also, the association between biomarkers and disease progression need to be examined further.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. A clinical diagnosis of IPF 2. Signed informed consent
Exclusion criteria
1. Clinical, radiological or histological findings inconsistent with a diagnosis of IPF 2. Inability or unwillingness to adhere to the study 3. Active on lung transplantation list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and type of comorbidities | Baseline | Prevalence of comorbidities at baseline |
| Health-related quality of life | Baseline, 6 months, 12 months, 24 months, 36 months | Change in St. George's Respiratory Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression in serum/plasma biomarker levels | Baseline, 6 months, 12 months, 24 months, 36 months | Increase or decrease in serum/plasma biomarker levels |
| Lung function tests | Baseline, 6 months, 12 months, 24 months, 36 months | Change in forced vital capacity |
| Disease progression | Baseline, 12 months, 24 months, 36 months | Change in interstitial changes on high resolution CT-scan (HRCT) |
| Health-related quality of life | Baseline, 6 months, 12 months, 24 months, 36 months | Change in Short Form 36 |
| 6-minute walk test | Baseline, 6 months, 12 months, 24 months, 36 months | Change in 6-minute walk test |
Countries
Denmark