Parkinsons disease
Conditions
Interventions
Inhalation of levodopa.
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent.;- Diagnosed with Parkinson*s disease;- At least 18 years old. ;- Currently on stable Parkinson*s disease levodopa regimen.;- Require levodopa containing medication regimen with a maximum of 4 administrations a day.;- Able to perform spirometry.
Exclusion criteria
Exclusion criteria: - Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent.;- Pregnant or breast feeding.;- Active pulmonary disease. ;- Patients with known symptomatic orthostatic hypotension.;- The use of COMT inhibitors and/or MAO-B inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum levodopa concentration in plasma (Cmax). Time to maximum concentration (Tmax). Area under the concentration time (minutes) curve at 0-180 min (AUC0-180) after administration of the dose (related to the actual dose administered (weighed dose minus remained dose in inhaler after inhalation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Absorption rate constant (Ka) of levodopa after pulmonary administration. Terminal elimination half life (T1/2el) of levodopa after pulmonary administration. Decrease of FEV1 in percentage measured by spirometry (at predose, 35 and 100 minutes after administration. Number of participants with adverse events (both spontaneously reported and reported as a result of questioning by the researcher. | — |
Countries
Netherlands
Outcome results
None listed