Small airways function testing in idiopathic pulmonary fibrosis (SWIFT-IPF)
Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)
We will use a breathing test called the nitrogen washout to see if adults with idiopathic pulmonary fibrosis have small airway problems before starting medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 2 sites (Milan, Lombardy and 1 other locations) |
| Trial ID | NCT07312305 on ClinicalTrials.gov |
What this trial studies
SWIFT-IPF is a prospective, observational multicenter project in Milan, Italy that uses the nitrogen washout (SBW-N₂) test to measure small airway dysfunction in adults with idiopathic pulmonary fibrosis prior to pharmacological therapy. The nitrogen washout test detects ventilation inhomogeneity and closing volume, which are functional markers of small airway disease. Eligible participants are adults diagnosed with IPF according to the 2022 ATS/ERS/JRS/ALAT guidelines and exclude those with prior chronic airway disease, bronchial obstruction, recent IPF exacerbation, or chronic use of systemic immunosuppressants or inhaled bronchodilators. No experimental treatments are given; the protocol relies on standard pulmonary function testing and clinical data collection across participating centers.
Who should consider this trial
Good fit: Adults (over 18) with a confirmed diagnosis of idiopathic pulmonary fibrosis per 2022 guidelines who can perform reproducible pulmonary function tests and are not on chronic inhaled bronchodilators or systemic immunosuppressants.
Not a fit: Patients with other chronic airway diseases, documented bronchial obstruction, recent IPF exacerbation, current chronic bronchodilator or immunosuppressive therapy, pregnancy, or inability to complete pulmonary function tests are unlikely to benefit from this assessment.
Why it matters
Potential benefit: If successful, this could help doctors identify small airway involvement early in IPF so monitoring and management can be better tailored to individual patients.
How similar studies have performed: There are no published studies that used nitrogen washout to detect small airway disease in untreated IPF patients, although small airway involvement has been suggested by imaging and pathological studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Lombardy and 1 other locations
- Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy) — 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 — Milan, Lombardy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.