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NCT07312305Recruiting

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

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
16 Dec 2025
Start date
15 May 2025
Primary completion date
15 May 2026
Lead sponsor
University of Milan
NCT number
NCT07312305

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 15 May 2025 to the primary completion date, 15 May 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Chronic therapy with long-acting bronchodilators or combinations of bronchodilators and inhaled corticosteroids
  • Chronic treatment with systemic corticosteroids or immunosuppressants
  • Concomitant lung or pleural cancer

Other

  • Refusal to participate in the study
  • Patients unable to provide informed consent for participation in the study
  • Presence of bronchial obstruction defined by an FEV1/FVC (or FEV1/VC) ratio below the lower limit of normal
  • Inability of the patient to perform reproducible pulmonary function tests
  • Pregnancy or breastfeeding women

Who the study is looking for

  • Age over 18 years
  • IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.