Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months
研究概览
简要总结
Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥40 years of age.
- •Patients that have signed Informed Consent Form.
- •Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
- •Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
- •Patients that are able to read, understand and complete the study specific questionnaires.
排除标准
- •Treatment with nintedanib for more than 7 days prior to study enrolment.
- •Patients receiving a combination therapy of nintedanib & pirfenidone for IPF.
- •Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
- •Prior treatment with pirfenidone or other treatment for IPF.
- •Participation in an interventional study.
- •Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.
研究组 & 干预措施
Nintedanib for patients with Idiopathic Pulmonary Fibrosis
干预措施: Nintedanib (Drug)
结局指标
主要结局
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months
时间窗: At baseline and at 3 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months
时间窗: At baseline and at 6 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months
时间窗: At baseline and at 9 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months
时间窗: At baseline and at 12 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.
次要结局
- Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)(At 3, 6, 9, and 12 months.)
- Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire(At baseline, and at 3, 6, 9, and 12 months.)
- Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score(At baseline and at 3, 6, 9, and 12 months.)
- Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)(At baseline, and at 3, 6, 9, and 12 months.)
- Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)(At baseline, and at 3, 6, 9, and 12 months.)