Real-world experiences of Inbrija for Parkinson's OFF episodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

INHALE-PD is a multicenter, non-interventional observational study in Austria, Germany, and Sweden. It will enroll adults with Parkinson’s who experience OFF episodes and are treated with Inbrija as part of their usual care. Using a mix of qualitative interviews and patient-reported outcomes, the study aims to describe OFF episode impact on daily living and quality of life and to explore factors influencing Inbrija use over about three months. The study will capture real-world experiences from up to 120 participants across approximately seven sites. Interventions involve the Levodopa inhalation powder used per routine clinical practice.

Why it matters

Who can join: the full rules

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®.

Where it's running

• Medizinischen Universität Graz
  Graz, Austria Recruiting
• Neurologisches Therapiezentrum Gmundnerberg GmbH
  Altmünster, Austria Not yet recruiting

Study contacts

• Study coordinator: Public Disclosure Manager
• Email: clinicaltrials@merz.de
• Phone: +496915030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.