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

Last updated: January 26, 2026
Sponsor: University of Milan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Idiopathic Pulmonary Fibrosis

Treatment

N/A

Clinical Study ID

NCT07312305
SWIFT-IPF
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age over 18 years

  • IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALATguidelines

Exclusion

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, chronicobstructive bronchitis, bronchiectasis with a cause other than IPF)

  • Presence of bronchial obstruction defined by an FEV1/FVC (or FEV1/VC) ratio belowthe lower limit of normal

  • Chronic therapy with long-acting bronchodilators or combinations of bronchodilatorsand 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 Design

Total Participants: 100
Study Start date:
May 15, 2025
Estimated Completion Date:
May 15, 2027

Connect with a study center

  • 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 3173435, Lombardy 3174618
    Italy

    Active - Recruiting

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

    Milan 3173435, Lombardy 3174618 20142
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.