An observational study in Parkinson Disease (PD), Parkinson's Disease and Off Episodes of Parkinson Disease, sponsored by Merz Therapeutics GmbH. Recruiting at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Merz Therapeutics GmbH (part of Merz Pharma) · Observational
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 120 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Merz Therapeutics GmbH is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adults with Parkinson's disease and a history of OFF episodes who have been prescribed Inbrija® (inhaled levodopa) as part of routine clinical practice. Participants will be recruited from neurology clinics and medical centers in Austria, Germany, and Sweden. The study includes both patients newly initiating Inbrija® and current Inbrija® users. Patients initiating Inbrija® will participate in the quantitative component and complete patient-reported outcome assessments over a 3-month period. A subset of current Inbrija® users will participate in qualitative interviews to describe their experiences of OFF episodes, treatment use, and the impact of Inbrija® on daily life and quality of life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the Quantitative Component:
For the Qualitative Component:
Exclusion Criteria:
For the Quantitative Component:
For the Qualitative Component:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®
Drug: Levodopa inhalation powder
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
Drug: Levodopa 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.
Also known as: Inbrija, Inhaled Levodopa
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From 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.
Time frame: Baseline to Month 3
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Months 1 and 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.
Time frame: Baseline to Month 1 and Month 2
Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores
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.
Time frame: Baseline to Months 1, 2, and 3
Patient Global Impression of Change (PGIC)
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.
Time frame: Months 1, 2, and 3
Patient Global Impression of Severity (PGIS)
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.
Time frame: Baseline, Month 1, Month 2, and Month 3
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 60 industry-sponsored observational studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 11 months is below that.
Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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