Real-world Patient Experiences With Inbrija® - Non-interventional Assessment of Inhaled Levodopa for the Management of OFF Episodes in Parkinson's Disease: a Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3
研究概览
简要总结
Parkinson's disease can cause OFF episodes, when medication effects wear off and symptoms return, affecting movement, daily activities, comfort, and wellbeing. This study aims to explore the experiences of people with Parkinson's disease who are prescribed Inbrija® as part of their usual care. Through a mixed-methods approach, the study will examine how OFF episodes affect patients, what influences their decision to use Inbrija®, and whether patient-reported outcomes related to symptoms, daily functioning, and quality of life change during the first 3 months of treatment.
The study is planned to be conducted at approximately 7 sites in Austria, Germany, and Sweden and will enroll up to 120 participants receiving Inbrija® in routine clinical practice.
详细描述
INHALE-PD is a multicenter, non-interventional observational study conducted in Austria, Germany, and Sweden. The study will enroll adults with Parkinson's disease who experience OFF episodes and have been prescribed Inbrija® as part of routine clinical care.
The study aims to characterize patient experiences of OFF episodes and to assess patient-reported outcomes associated with Inbrija® use in routine clinical practice.
Using qualitative interviews and patient-reported outcome assessments, the study will explore the impact of OFF episodes on patients' daily lives, factors influencing the use of Inbrija®, and changes in patient-reported outcomes during the observation period.
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
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of Parkinson's disease with a history of OFF episodes.
- •Able and willing to provide informed consent.
- •For the Quantitative Component:
- •Physician decision to initiate Inbrija® for the treatment of OFF episodes in Parkinson's disease according to routine clinical practice prior to enrollment.
- •For the Qualitative Component:
- •Current user of Inbrija® for OFF episodes in Parkinson's disease according to approved prescribing conditions.
- •At least 6 weeks of regular Inbrija® use (minimum 4 uses during the previous month).
- •Able to participate in a 60-minute interview using an internet-enabled device.
排除标准
- •For the Quantitative Component:
- •Previous use of Inbrija® before study enrollment.
- •Participation in an interventional Parkinson's disease clinical trial within 3 months prior to Inbrija® initiation.
- •Residence outside Austria, Germany, or Sweden.
- •Current use of an on-demand treatment for OFF episodes other than Inbrija®.
- •For the Qualitative Component:
- •Participation in an interventional Parkinson's disease clinical trial within 3 months prior to enrollment.
- •Residence outside Austria or Germany.
- •Current use of an on-demand treatment for OFF episodes other than Inbrija®.
研究组 & 干预措施
Qualitative Cohort
Adults with Parkinson's disease and a history of OFF episodes who are current users of Inbrija® in routine clinical practice. Participants complete a qualitative interview to explore their experiences of OFF episodes and treatment with Inbrija®
干预措施: Levodopa inhalation powder (Drug)
Quantitative Cohort
Adults with Parkinson's disease and a history of OFF episodes who are initiating Inbrija® in routine clinical practice. Participants complete patient-reported outcome assessments during the observational follow-up period
干预措施: Levodopa inhalation powder (Drug)
结局指标
主要结局
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3
时间窗: Baseline to Month 3
Mean within-patient change in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility domain score from baseline (before initiation of Inbrija®) to Month 3. The PDQ-39 Mobility domain includes 10 items assessing mobility-related difficulties experienced by patients with Parkinson's disease. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse mobility and poorer health-related quality of life.
次要结局
- Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Months 1 and 2(Baseline to Month 1 and Month 2)
- Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores(Baseline to Months 1, 2, and 3)
- Patient Global Impression of Change (PGIC)(Months 1, 2, and 3)
- Patient Global Impression of Severity (PGIS)(Baseline, Month 1, Month 2, and Month 3)