Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Milan
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.
Overview
Brief Summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, fibrosing, and progressive lung disease of unknown cause, whose incidence increases proportionally from the age of 60. It is characterized by a poor prognosis. Antifibrotic therapy can slow the progression of the disease and reduce mortality, but the life expectancy is less than 7-10 years in the vast majority of patients with IPF. There are no studies in the literature that have evaluated the presence of small airway disease in patients with IPF prior to the initiation of pharmacological therapy, using the nitrogen washout test. This test is currently considered the only non-invasive method capable of detecting ventilation inhomogeneity and closing volume, which are indicators of small airway dysfunction. The investigators carried out an Italian prospective, observational, multicenter study with the primary aim to assess the prevalence of small airway disease measured by the nitrogen washout test (evaluating the following functional parameters: phase 3 slope, closing volume, closing capacity, closing volume/vital capacity, closing capacity/total lung capacity, and phase 4 slope) in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy. During outpatients visits clinical, functional and radiological data will be collected. Results will be compared to an healthy control group matched with IPF population. Variations in small airways disease parameters will be assessed after one year of antifibrotic treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years
- •IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines
Exclusion Criteria
- •Refusal to participate in the study
- •Patients unable to provide informed consent for participation in the study
- •IPF exacerbation in the 6 months prior to enrollment
- •Previous diagnosis of chronic airway disease (e.g., bronchial asthma, chronic obstructive bronchitis, bronchiectasis with a cause other than IPF)
- •Presence of bronchial obstruction defined by an FEV1/FVC (or FEV1/VC) ratio below the lower limit of normal
- •Chronic therapy with long-acting bronchodilators or combinations of bronchodilators and inhaled corticosteroids
- •Inability of the patient to perform reproducible pulmonary function tests
- •Chronic treatment with systemic corticosteroids or immunosuppressants
- •Concomitant lung or pleural cancer
- •Pregnancy or breastfeeding women
Arms & Interventions
IPF
IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines
Outcomes
Primary Outcomes
Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.
Time Frame: 1 year
To evaluate the percentage of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy, with small airway disease measured by the nitrogen washout test (assessing the following functional parameters: phase 3 slope, closing volume, closing capacity, closing volume/vital capacity, closing capacity/total lung capacity, and phase 4 slope).
Secondary Outcomes
- Prevalence of tidal expiratory flow limitation at the time of diagnosis, before the initiation of antifibrotic therapy and after one year of antifibrotic treatment.(1 year)
- Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.(1 year)
- To compare the indices of small airway dysfunction and the prevalence of small airway disease in patients with IPF and age-matched healthy subjects(1 year)
- Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease(1 year)
- Relationship between exercise performance and the presence and severity of small airway disease(1 year)
- Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone(1 year)
- Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan(1 year)
- Relationship between dyspnea degree and the presence and severity of small airway disease.(1 year)
- Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents(1 year)
- Relationship between different scores as the GAP index, CPI, KBILD and UCSD Shortness of Breath Questionnaire, and the presence and severity of small airway disease(1 year)
- Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment.(1 year)
Investigators
Michele Mondoni
MD, Associated Professor of Respiratory Medicine
University of Milan