Inhalation of Levodopa in Parkinson's disease
Completed
- Conditions
- Parkinson's diseaseziekte van Parkinson
- Registration Number
- NL-OMON25573
- Lead Sponsor
- Department of Pharmaceutical Technology and Biopharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen
- Brief Summary
Can Patients with Parkinson’s Disease Use Dry Powder Inhalers during Off Periods? 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
Signed informed consent.
Diagnosed with Parkinson’s disease
Exclusion Criteria
Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent.
Pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum levodopa concentration in plasma(Cmax).<br /><br>Time to maximum concentration (Tmax).<br /><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).<br>
- Secondary Outcome Measures
Name Time Method Absorption rate constant (Ka) of levodopa after pulmonary administration.<br /><br>Terminal elimination half life (T1/2el) of levodopa after pulmonary administration.<br /><br>Decrease of FEV1 in percentage measured by spirometry (at predose, 35 and 100 minutes after administration.<br /><br>Number of participants with adverse events (both spontaneously reported and reported as a result of questioning by the researcher. <br>