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

Обзор

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.

Первичные конечные точки

• Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy. [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease. [Срок оценки: 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 [Срок оценки: 1 year]
• Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease [Срок оценки: 1 year]
• Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone [Срок оценки: 1 year]
• Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan [Срок оценки: 1 year]
• Relationship between exercise performance and the presence and severity of small airway disease [Срок оценки: 1 year]
• Relationship between dyspnea degree and the presence and severity of small airway disease. [Срок оценки: 1 year]
• Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents [Срок оценки: 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 [Срок оценки: 1 year]
• Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment. [Срок оценки: 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. [Срок оценки: 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of M — Milan
• Division of Respiratory Diseases, L. Sacco University Hospital, ASST Fatebenefratelli-Sacc — Milan

Идентификаторы

NCT: NCT07312305 · SWIFT-IPF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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