Off Episodes of Parkinson Disease, Parkinson Disease (PD), Parkinson's Disease
Conditions
Keywords
OFF episodes, Patient experience, Parkinson Disease, Motor Fluctuations, Inbrija, Levodopa Inhalation Powder, Inhaled Levodopa, Patient-Reported Outcomes, Quality of Life, PDQ-39, Mobility, Activities of daily living (ADL), Fatigue, Stigma, Health-Related Quality of Life, Real-World Study, Observational Study, Mixed-Methods Study
Brief summary
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.
Detailed description
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.
Interventions
DRUGLevodopa inhalation powder
Levodopa inhalation powder (Inbrija®) prescribed as part of routine clinical practice for the intermittent treatment of OFF episodes in adults with Parkinson's disease receiving levodopa therapy. In this non-interventional study, treatment is determined by the treating physician independently of study participation, and no study medication is assigned by the protocol.
Sponsors
Merz Therapeutics GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
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®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility domain score from baseline to Month 1 and Month 2. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse mobility and poorer health-related quality of life. |
| Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores | Baseline to Months 1, 2, and 3 | Mean within-patient change in Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living (ADL), Bodily Discomfort, Stigma, and Total scores from baseline to Months 1, 2, and 3. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse health-related quality of life. |
| Patient Global Impression of Change (PGIC) | Months 1, 2, and 3 | Proportion of patients in each Patient Global Impression of Change (PGIC) response category following initiation of Inbrija®. PGIC assesses the patient's perception of overall change in OFF episodes since starting treatment. |
| Patient Global Impression of Severity (PGIS) | Baseline, Month 1, Month 2, and Month 3 | Proportion of patients in each Patient Global Impression of Severity (PGIS) response category at baseline and following initiation of Inbrija®. PGIS is a single-item measure that assesses the patient's overall severity of OFF episodes, with response categories of None, Mild, Moderate, Severe, and Very Severe. |
Countries
Austria
Contacts
CONTACTPublic Disclosure Manager
STUDY_DIRECTORMerz Therapeutics Medical Expert
Merz Therapeutics GmbH
Outcome results
None listed