Idiopathic Pulmonary FibrosisSWIFT-IPFNCT07312305
Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)
An observational study of Idiopathic Pulmonary Fibrosis and Small Airways Disease, run by University of Milan at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Small Airways Disease
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 15 May 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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).
Who may be able to join
- Age over 18 years
- IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
Milan, Lombardy, 20142
Jacopo Cefalo, MD, +390281843025, jacopo.cefalo@asst-santipaolocarlo.it
Carmine Salerni, MD, +390240222488, carmine.salerni@asst-santipaolocarlo.it
- Recruiting
Division of Respiratory Diseases, L. Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy. Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, Milano, Italy
Milan, Lombardy
Dejan Radovanovic, MD, +39 0239042277, dejan.radovanovic@unimi.it
Valentina Fraccon, MD, +390239042372, valentina.fraccon@unimi.it
About this study
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.
- Keywords
- IPF, SAD, SBW-N₂
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IPF | IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (11)
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.
Measured: 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
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).
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan
To evaluate the correlation between functional characteristics: forced expiratory flow at 25-75% of vital capacity (FEF25-75), forced vital capacity (FVC) and diffusing of the lung for carbon monoxide (DLCO) with parameters of small airway dysfunction from the Single Breath Nitrogen (SBN2) test, as well as disease extent indices on chest CT-scan
Measured: 1 year
Relationship between exercise performance and the presence and severity of small airway disease
To evaluate the relationship between exercise performance (meters, oxygen saturation nadir), assessed by the six-minute walk test distance, and the presence and severity of small airway disease
Measured: 1 year
Relationship between dyspnea degree and the presence and severity of small airway disease.
To evaluate the relationship between the degree of dyspnea, measured by the modified Medical Research Council (mMRC) scale, and the presence and severity of small airway disease.
Measured: 1 year
Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents
To evaluate the clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents (alveolar volume - VA <80% predicted, Transfer Coefficient of CO - KCO <80% predicted, ventilation inhomogeneity - VA/Total Lung Capacity (TLC) <0.8)
Measured: 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
To evaluate the relationship between different scores as the Gender Age Physiology (GAP) index, Composite Physiologic Index (CPI) , the King's Brief Interstitial Lung Disease (KBILD) score and the University of California San Diego (UCSD) Shortness of Breath Questionnaire, and the presence and severity of small airway disease;
Measured: 1 year
Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment.
Evaluate presence and variation of small airway dysfunction parameters from the Single Breath Nitrogen (SBN2) test in IPF patients after one year of antifibrotic therapy.
Measured: 1 year
Prevalence of tidal expiratory flow limitation at the time of diagnosis, before the initiation of antifibrotic therapy and after one year of antifibrotic treatment.
To evaluate the percentage of patients with IPF with tidal expiratory flow limitation measured by means of Negative Expiratory Pressure (NEP), at the time of diagnosis, before the initiation of antifibrotic therapy and after one year of therapy with antifibrotic treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Mondoni, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312305
- Sponsor's protocol ID
- SWIFT-IPF
- Acronym
- SWIFT-IPF
- Status last verified
- Oct 2025
- First submitted
- 16 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)
- ClinicalTrials.gov ID
- NCT07312305
- Acronym / sponsor ID
- SWIFT-IPF / SWIFT-IPF
- Keywords
- IPF, SAD, SBW-N₂
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 31 Dec 2025 (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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF | – | –IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (2 listed)
- Age over 18 years
- IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
11 secondary outcomes
Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.
Time frame: 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
Time frame: 1 year
Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease
Time frame: 1 year
Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone
Time frame: 1 year
Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan
Time frame: 1 year
Relationship between exercise performance and the presence and severity of small airway disease
Time frame: 1 year
Relationship between dyspnea degree and the presence and severity of small airway disease.
Time frame: 1 year
Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents
Time frame: 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
Time frame: 1 year
Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment.
Time frame: 1 year
Prevalence of tidal expiratory flow limitation at the time of diagnosis, before the initiation of antifibrotic therapy and after one year of antifibrotic treatment.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
Milan, Italy
Division of Respiratory Diseases, L. Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy. Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, Milano, Italy
Milan, Italy
2 sites 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 Small Airways Disease, run by University of Milan at 2 sites in Italy.
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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 28 Jan 2026.