NCT05492994已完成不适用
Longitudinal Study Without an Investigational Medicinal Product in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) to Evaluate Novel Imaging-based Biomarkers in Comparison With Lung Function for Use in Early Clinical Development
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
研究概览
简要总结
The main objectives of this imaging biomarker study are to assess the annual lung function change in patients with progressive fibrosing interstitial lung disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP Computer Tomography (CT) pattern, and to monitor lung structural changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the study.
- •Patients with a documented diagnosis of Progressive Fibrosing Interstitial Lung Disease (PF-ILD) including Idiopathic Pulmonary Fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP chest Computer Tomography (CT) pattern and no anti-fibrotic treatment (nintedanib or pirfenidone) at baseline and previously (treatment-naive regarding Standard of Care (SoC))
- •Male or female patients aged ≥ 40 years when signing the informed consent.
- •Forced Vital Capacity (FVC) ≥ 45% predicted of normal reviewed at Visit
- •Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for Haemoglobin ≥ 25% of predicted normal reviewed at Visit
- •Body mass index (BMI) <=30 kg/m2 reviewed at Visit
- •Glomerular filtration rate (GFR) ≥30 ml/min reviewed at Visit
- •Supportive Thyroid-Stimulating Hormone (TSH) evaluation for all participants >60 years and/or history of thyroid disease according to local standard procedures at Visit 1.
排除标准
- •Significant pulmonary disease other than PF-ILD or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following:
- •Put the patient at risk because of participation in the study
- •Influence the results of the study
- •Cause concern regarding the patient's ability to participate in the study Patients with a history of a documented Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection will be excluded if lung changes due to the infection have been observed at screening (on discretion of the investigator).
- •Any documented active or suspected malignancy or history of malignancy on discretion of the investigator.
- •Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the accurate assessment of endpoints of the study.
- •Patients not able to understand or follow study procedures or patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g., chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant).
- •Previous enrolment in this study.
- •Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
- •Women who are pregnant, nursing, or who plan to become pregnant while in the study. Women of childbearing potential1 not willing or able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2). A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol.
- •Life expectancy for disease other than Interstitial Lung Disease (ILD) <2.5 years (investigator assessment) Further exclusion criteria apply.
研究组 & 干预措施
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Experimental
干预措施: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (Diagnostic Test)
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Experimental
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Experimental
干预措施: Chest Computer Tomography (Diagnostic Test)
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Experimental
干预措施: Blood biomarker analysis (Diagnostic Test)
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Experimental
干预措施: Spirometry (Diagnostic Test)
结局指标
主要结局
Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
时间窗: at baseline and at week 52
次要结局
- Absolute change in fibrosis extent in % of lung volume determined on chest Computer Tomography (CT) from baseline to week 52(at baseline and at week 52)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Evaluation of lung function imaging biomarkers from MRI during the convalescent phase of COVID-19 infection in a monocentric cohortong-COVIDDRKS00032159MU München150
已完成
不适用
A Longitudinal, Observational Study of Primary Ciliary Dyskinesia in AdultsPrimary Ciliary DyskinesiaNCT05685186ReCode Therapeutics31
已完成
不适用
Effects of an Intervention Program Based on Pain Education in Patients With Chronic Pelvic PainPelvic PainNCT02957214University of Valencia15
未知
Unknown
A non-interventional study to assess lung function in Japanese children and elderlyAJPRN-jRCT1080223039DAIICHISANKYO Co.,Ltd.46
已完成
不适用
A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)AsthmaNCT04808518AstraZeneca74