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

NCT ID: NCT07312305

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2027-05-15

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.

Conditions

Idiopathic Pulmonary Fibrosis; Small Airways Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IPF

IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Michele Mondoni

MD, Associated Professor of Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)

Milan, Lombardy, Italy

Site Status: 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, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Jacopo Cefalo, MD

Role: primary

jacopo.cefalo@asst-santipaolocarlo.it

+390281843025

Carmine Salerni, MD

Role: backup

carmine.salerni@asst-santipaolocarlo.it

+390240222488

Dejan Radovanovic, MD

Role: primary

dejan.radovanovic@unimi.it

+39 0239042277

Valentina Fraccon, MD

Role: backup

valentina.fraccon@unimi.it

+390239042372

Other Identifiers

SWIFT-IPF

Identifier Type: -

Identifier Source: org_study_id