PMID- 33130477
OWN - NLM
STAT- MEDLINE
DCOM- 20211101
LR  - 20211101
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 81
DP  - 2020 Dec
TI  - A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation 
      powder (CVT-301, Inbrija) in patients with Parkinson's disease.
PG  - 144-150
LID - S1353-8020(20)30822-1 [pii]
LID - 10.1016/j.parkreldis.2020.10.029 [doi]
AB  - INTRODUCTION: CVT-301 (Inbrija(R)) is a levodopa inhalation powder for on-demand 
      treatment of OFF episodes in Parkinson's disease patients treated with 
      carbidopa/levodopa. Safety and efficacy results of a 12-month, dose-level blinded 
      extension study of a phase 3 trial (SPAN℠-PD) of CVT-301 are presented. METHODS: 
      Patients were receiving oral carbidopa/levodopa and adjunctive CVT-301 treatment, 
      blinded to dose (60 mg or 84 mg, N = 325). Study visits occurred every 3 months. 
      Pulmonary function was assessed by spirometry. Other safety assessments included 
      dyskinesia and adverse events (AEs). Secondary objectives of the study included 
      maintenance of improvement assessments for occurrence of an ON state during the 
      60-min post-dose period, change in total daily OFF time, and Patient Global 
      Impression of Change (PGIC). RESULTS: Most frequent AEs (>/=5%) were cough (15.4%), 
      fall (13.1%), upper respiratory tract infection (7.1%), and dyskinesia (5.1%). 
      Severe AEs (>1 event) were cough (1.9%) and dyskinesia (0.6%). Twelve-month mean 
      changes from baseline for FEV(1), FVC, and DL(CO) were -0.092 L, -0.097 L, and 
      -0.922 mL/min/mmHg, respectively. At 12 months, 73.0% of patients on 84 mg 
      achieved an ON state within 60 min. Total daily OFF time was reduced by 0.55 h 
      (month 1) and 0.88 h (month 12) for the 84 mg dose. Percentage of patients 
      self-reported as improved by PGIC was 65.5-91.9% over 12 months. CONCLUSION: 
      CVT-301 was generally well-tolerated. Twelve-month decline in pulmonary function 
      was consistent with a prior PD control group. Exploratory efficacy results showed 
      CVT-301 maintained improvement at achieving ON states in patients experiencing 
      OFF episodes, decreasing daily OFF time, and maintaining improvement in PGIC.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Farbman, Eric S
AU  - Farbman ES
AD  - Roseman University of Health Sciences, Las Vegas, NV, USA. Electronic address: 
      efarbman@roseman.edu.
FAU - Waters, Cheryl H
AU  - Waters CH
AD  - Columbia University Medical Center, New York, NY, USA.
FAU - LeWitt, Peter A
AU  - LeWitt PA
AD  - Department of Neurology, Henry Ford Hospital and Wayne State University School of 
      Medicine, West Bloomfield, MI, USA.
FAU - Rudzinska, Monika
AU  - Rudzinska M
AD  - Department of Neurology, Faculty of Medicine and Health Sciences, Andrzej Frycz 
      Modrzewski Krakow University, Krakow, Poland.
FAU - Klingler, Michael
AU  - Klingler M
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Lee, Angela
AU  - Lee A
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Qian, Jenny
AU  - Qian J
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Oh, Charles
AU  - Oh C
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - Parkinson's Disease and Movement Disorders Center, University of South Florida, 
      Tampa, FL, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201017
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Dopamine Agonists)
RN  - 0 (Drug Combinations)
RN  - 0 (Powders)
RN  - 0 (carbidopa, levodopa drug combination)
RN  - 46627O600J (Levodopa)
RN  - MNX7R8C5VO (Carbidopa)
SB  - IM
MH  - Administration, Inhalation
MH  - Aged
MH  - Carbidopa/pharmacology
MH  - Dopamine Agonists/administration & dosage/adverse effects/*pharmacology
MH  - Drug Combinations
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Levodopa/administration & dosage/adverse effects/*pharmacology
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Powders
MH  - Single-Blind Method
MH  - Spirometry
OTO - NOTNLM
OT  - Inbrija
OT  - Inhaled levodopa
OT  - OFF episodes
OT  - Spirometry
OT  - Treatment
EDAT- 2020/11/02 06:00
MHDA- 2021/11/03 06:00
CRDT- 2020/11/01 20:38
PHST- 2019/11/08 00:00 [received]
PHST- 2020/10/07 00:00 [revised]
PHST- 2020/10/15 00:00 [accepted]
PHST- 2020/11/02 06:00 [pubmed]
PHST- 2021/11/03 06:00 [medline]
PHST- 2020/11/01 20:38 [entrez]
AID - S1353-8020(20)30822-1 [pii]
AID - 10.1016/j.parkreldis.2020.10.029 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2020 Dec;81:144-150. doi: 
      10.1016/j.parkreldis.2020.10.029. Epub 2020 Oct 17.