A more rapid rise of the levodopa plasma level after inhalation compared to oral administration of levodopa.
ID
Bron
Verkorte titel
Aandoening
Parkinson's disease
ziekte van Parkinson
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Maximum levodopa concentration in plasma(Cmax).<br>
Time to maximum concentration (Tmax).<br>
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).
Achtergrond van het onderzoek
-
Doel van het onderzoek
A more rapid rise of the levodopa plasma level after inhalation compared to oral administration of levodopa.
Onderzoeksopzet
3 visits: at least 1 week between 2 visits and all visits within 6 months.
Onderzoeksproduct en/of interventie
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.
Publiek
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Wetenschappelijk
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5326 |
| NTR-old | NTR5435 |
| Ander register | - : ParkinsonDPI-2 |
Samenvatting resultaten
M. Luinstra, A. W. F. Rutgers, H. Dijkstra et al. Published: July 14, 2015. DOI: 10.1371/journal.pone.0132714
<br><br>
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