No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease
ziekte van Parkinson
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
-
Study objective
A more rapid rise of the levodopa plasma level after inhalation compared to oral administration of levodopa.
Study design
3 visits: at least 1 week between 2 visits and all visits within 6 months.
Intervention
First visit: inhalation of 30 mg levodopa inhalation powder.
Second visit: inhalation of 60 mg levodopa inhalation powder.
Third visit: regular oral levodopa medication.
During all three visits, the participants undergo spirometry (lung function testing) and multiple bloodsamples are drawn.
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5326 |
| NTR-old | NTR5435 |
| Other | - : ParkinsonDPI-2 |
Summary results
M. Luinstra, A. W. F. Rutgers, H. Dijkstra et al. Published: July 14, 2015. DOI: 10.1371/journal.pone.0132714
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A levodopa dry powder inhaler for the treatment of Parkinson's disease patients in off periods. M. Luinstra, F. Grasmeijer, P. Hagedoorn et al. Eur J Pharm Biopharm. 2015 Oct 7. pii: S0939-6411(15)00404-X. doi: 10.1016/j.ejpb.2015.10.003