Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines
Disqualifiers
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)
Trial population
Patients with IPF of any severity diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines, attending the specialist outpatient clinics of the Pulmonology Units of ASST Santi Paolo e Carlo and ASST Fatebenefratelli-Sacco (Milan, Italy).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: IPF
Trial outcomes
Primary outcomes
1
Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.
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).
Time frame
1 yearSecondary outcomes
1
Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.
To evaluate the relationship between CT features (radiologic pattern type, presence/absence of mediastinal lymphadenopathy, presence/absence of any type of emphysema involving ≥5% of total lung volume, extent of disease, disease progression, air trapping, black lung) and functional parameters indicative of small airway disease.
Time frame
1 year2
To compare the indices of small airway dysfunction and the prevalence of small airway disease in patients with IPF and age-matched healthy subjects
To compare the indices of small airway dysfunction and the prevalence of small airway disease in patients with IPF and age-matched healthy subjects (without respiratory comorbidities).
Time frame
1 year3
Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease
To study the relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease
Time frame
1 year4
Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone
To compare the prevalence of small airway disease in patients with IPF and concomitant emphysema (combined pulmonary fibrosis and emphysema, CPFE), defined as the presence of any type of emphysema involving ≥5% of total lung volume, with patients with IPF alone.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov