Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF) (SWIFT-IPF)

January 26, 2026 updated by: Michele Mondoni, University of Milan
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20142
        • Recruiting
        • Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jacopo Cefalo, MD
        • Sub-Investigator:
          • Carmine Salerni, MD
        • Sub-Investigator:
          • Giulia Nalesso, MD
        • Principal Investigator:
          • Michele Mondoni, MD, Prof.
      • Milan, Lombardy, Italy
        • 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
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierachille Santus, MD, Prof.
        • Sub-Investigator:
          • Fiammetta Danzo, MD
        • Sub-Investigator:
          • Valentina Fraccon, MD
        • Sub-Investigator:
          • Peter Dilov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
IPF
IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
1 year
Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease
Time Frame: 1 year
To study the relationship between clinical and epidemiological characteristics of the cohort 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
Time Frame: 1 year
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.
1 year
Relationship between exercise performance and the presence and severity of small airway disease
Time Frame: 1 year
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
1 year
Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.
Time Frame: 1 year
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.
1 year
Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan
Time Frame: 1 year
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
1 year
Relationship between dyspnea degree and the presence and severity of small airway disease.
Time Frame: 1 year
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.
1 year
Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents
Time Frame: 1 year
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)
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
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;
1 year
Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment.
Time Frame: 1 year
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.
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
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWIFT-IPF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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