An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 72
- 主要终点
- Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry
研究概览
简要总结
This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comply with the study protocol, in the Investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires
- •Suspicion of IPF/ILD: radiological evidence of IPF/ILD in symptomatic participants (unexplained dyspnea on exertion and/or cough)
排除标准
- •Participation in any investigational study within 28 days prior to inclusion
- •History of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the Investigator
- •Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease
结局指标
主要结局
Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry
时间窗: From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS
Minimum site visits were: baseline, diagnosis, and EOS for each participant. From inclusion into the study, participants were followed for up to12 months. The EOS was defined as: If no diagnosis was made 12 months after inclusion, the participant left the study; Participants diagnosed with non-ILD left the study on the date of diagnosis; Participants diagnosed with IPF or non-IPF ILD were followed up to the start of drug treatment (within 6 months) or up to 6 months if no drug treatment was prescribed. Therefore, the total length of the study was variable for each participant. Measurements were taken daily by home spirometry. The semi-annual mean FVC decline was calculated by use of the estimated semi-annual FVC decline of each individual participant. The individual FVC decline was estimated by applying a linear regression model to all acceptable FVC measurements flagged as 'Good blow' collected by the individual participant during the entire peri-diagnostic period (up to 18 months).
次要结局
- Change From Baseline in the FVC Decline in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured in mL by Site Spirometry(From Baseline to end of the study (up to 18 months))
- Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry(From Baseline to end of the study (up to 18 months))
- Change From Baseline in Distance Walked (Meters) on the 6MWT in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Assessed at Site(From Baseline to end of the study (up to 18 months))
- Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants Requiring Respiratory-Related Hospitalizations(From inclusion into the study to end of the study (up to 18 months))
- Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry(From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS)
- Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry(From inclusion into the study to end of the study (up to 18 months))
- Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry(From inclusion into the study to end of the study (up to 18 months))
- Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants With Events Related to the Study Assessments(From inclusion into the study to end of the study (up to 18 months))
- The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Pearson's Correlation Coefficient of Physical Functional Capacity Assessed at Home in Terms of the Decline in the Number of Footsteps and on Site in Terms of the Decline in Distance of the 6MWT(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants Who Died Due to Respiratory-Related Diseases(From inclusion into the study to end of the study (up to 18 months))
- The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants With Non-Elective Hospitalizations(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants With Investigator-Reported Acute Exacerbations(From inclusion into the study to end of the study (up to 18 months))
- Percentage of Participants Who Died Due to Any Cause(From inclusion into the study to end of the study (up to 18 months))