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临床试验/NCT07312305
NCT07312305招募中不适用

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

University of Milan2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

IPF

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

结局指标

主要结局

Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.

时间窗: 1 year

To evaluate the percentage of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy, with small airway disease measured by the nitrogen washout test (assessing the following functional parameters: phase 3 slope, closing volume, closing capacity, closing volume/vital capacity, closing capacity/total lung capacity, and phase 4 slope).

次要结局

  • Prevalence of tidal expiratory flow limitation at the time of diagnosis, before the initiation of antifibrotic therapy and after one year of antifibrotic treatment.(1 year)
  • Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.(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(1 year)
  • Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease(1 year)
  • Relationship between exercise performance and the presence and severity of small airway disease(1 year)
  • Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone(1 year)
  • Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan(1 year)
  • Relationship between dyspnea degree and the presence and severity of small airway disease.(1 year)
  • Clinical and functional characteristics of IPF patients with different alterations in the DLCO subcomponents(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(1 year)
  • Variation of small airway dysfunction parameters in IPF patients after one year of antifibrotic treatment.(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Mondoni

MD, Associated Professor of Respiratory Medicine

University of Milan

研究点 (2)

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