Parkinson Disease (PD)INHALE-PDNCT07797790
Real-world Patient Experiences With Inbrija®
An observational study of Parkinson Disease (PD) and Parkinson's Disease, run by Merz Therapeutics GmbH at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD), Parkinson's Disease, Off Episodes of Parkinson Disease
- What is being tested?
- Levodopa inhalation powder
- How many people
- 120 participants
- Where
- 2 sitesAustria
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- 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®.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Not yet recruiting
Neurologisches Therapiezentrum Gmundnerberg GmbH
Altmünster, 4813
- Recruiting
Medizinischen Universität Graz
Graz, 8010
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Levodopa inhalation powder
- 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
- Medical subject headings
- Parkinson Disease, Fatigue, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa inhalation powderDrug
Also called Inbrija, Inhaled Levodopa
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.
| Study group | Role | What they receive |
|---|---|---|
| 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® Receives: Drug: Levodopa inhalation powder | |
| 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 Receives: Drug: Levodopa inhalation powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 3
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Therapeutics Medical Expert, Study director, Merz Therapeutics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797790
- Sponsor's protocol ID
- M900641001
- Acronym
- INHALE-PD
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07797790
- Acronym / sponsor ID
- INHALE-PD / M900641001
- Keywords
- OFF episodes, Patient experience, Parkinson Disease, Motor Fluctuations, Inbrija, Levodopa Inhalation Powder, Inhaled Levodopa, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Merz Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative Cohort | – | Drug: Levodopa inhalation powderAdults 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® |
| Quantitative Cohort | – | Drug: Levodopa inhalation powderAdults 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Adults aged 18 years or older.
- Diagnosis of Parkinson's disease with a history of OFF episodes.
- Able and willing to provide informed consent.
- Physician decision to initiate Inbrija® for the treatment of OFF episodes in Parkinson's disease according to routine clinical practice prior to enrollment.
- Current user of Inbrija® for OFF episodes in Parkinson's disease according to approved prescribing conditions.
Key exclusion criteria (9 listed)
- 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®.
- Participation in an interventional Parkinson's disease clinical trial within 3 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa inhalation powderAlso: Inbrija, Inhaled LevodopaLevodopa 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. | Drug | Qualitative Cohort, Quantitative Cohort |
Primary outcome
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3
Time frame: 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.
4 secondary outcomes
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Months 1 and 2
Time frame: Baseline to Month 1 and Month 2
Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores
Time frame: Baseline to Months 1, 2, and 3
Patient Global Impression of Change (PGIC)
Time frame: Months 1, 2, and 3
Patient Global Impression of Severity (PGIS)
Time frame: Baseline, Month 1, Month 2, and Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merz Therapeutics Medical Expert study director
Merz Therapeutics GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD) and Parkinson's Disease, run by Merz Therapeutics GmbH at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Public Disclosure Manager (+496915030, clinicaltrials@merz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3 (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.