Inhaled levodopa in Parkinson's disease patients with OFF periods: A randomized 12-month pulmonary safety study.
Adult
Aged
Aged, 80 and over
Antiparkinson Agents
/ administration & dosage
Female
Follow-Up Studies
Humans
Levodopa
/ administration & dosage
Lung
/ drug effects
Lung Diseases
/ chemically induced
Male
Middle Aged
Outcome Assessment, Health Care
Parkinson Disease
/ drug therapy
Patient Reported Outcome Measures
Respiratory Function Tests
Efficacy
Inhaled levodopa
Motor fluctuations
Off periods
Safety
Journal
Parkinsonism & related disorders
ISSN: 1873-5126
Titre abrégé: Parkinsonism Relat Disord
Pays: England
ID NLM: 9513583
Informations de publication
Date de publication:
02 2020
02 2020
Historique:
received:
09
05
2019
revised:
20
09
2019
accepted:
20
12
2019
pubmed:
14
1
2020
medline:
9
1
2021
entrez:
14
1
2020
Statut:
ppublish
Résumé
CVT-301 is an orally inhaled levodopa therapy approved for the intermittent treatment of OFF episodes in Parkinson's disease patients who are taking a standard oral levodopa regimen. This open-label, randomized, controlled study over 12 months characterizes the safety, including pulmonary safety, of CVT-301 84 mg (nominal respirable levodopa fine-particle dose, 50 mg). Patients experiencing motor fluctuations were randomized 2:1 to CVT-301 or an observational cohort (OC) receiving oral standard of care. Pulmonary safety was assessed using spirometry and carbon monoxide diffusion capacity (DL Of 408 patients randomized, 310 completed the study (204 in CVT-301 and 106 in OC). Mean 12-month changes from baseline for CVT-301 were -0.105 L (FEV CVT-301 84 mg induced no clinically significant differences in pulmonary function compared with the OC. Improvements in motor scores, OFF time, and patient-reported outcomes support clinical efficacy for up to 12 months.
Identifiants
pubmed: 31927343
pii: S1353-8020(19)30531-0
doi: 10.1016/j.parkreldis.2019.12.012
pii:
doi:
Substances chimiques
Antiparkinson Agents
0
Levodopa
46627O600J
Types de publication
Journal Article
Observational Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4-10Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.