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NCT Number: NCT07797790

Real-world Patient Experiences With Inbrija®

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.

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Fatigue Movement Disorders Nervous System Diseases Neurodegenerative Diseases Off Episodes of Parkinson Disease Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Social Behavior Social Stigma Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurologisches Therapiezentrum Gmundnerberg GmbH

Altmünster, 4813, Austria

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

Levodopa inhalation powder

Drug

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.

Other names: Inbrija, Inhaled Levodopa

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores

    Time frame: 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.

  3. Patient Global Impression of Change (PGIC)

    Time frame: 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.

  4. Patient Global Impression of Severity (PGIS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Public Disclosure Manager

CONTACT

[email protected]

+496915030

Sponsors and collaborators

Lead sponsor

Merz Therapeutics GmbH

Industry

Registry information

Official study 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

Acronym: INHALE-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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