A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson's disease
| Autor: | Michael Klingler, Angela Lee, Jenny Qian, Robert A. Hauser, Cheryl Waters, Monika Rudzińska, Eric S. Farbman, Peter A. LeWitt, Charles Oh |
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| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine Spirometry Levodopa Drug-Related Side Effects and Adverse Reactions Pulmonary function testing 03 medical and health sciences FEV1/FVC ratio 0302 clinical medicine Administration Inhalation Outcome Assessment Health Care medicine Humans Single-Blind Method Adverse effect Aged medicine.diagnostic_test business.industry Carbidopa Middle Aged medicine.disease Drug Combinations 030104 developmental biology Upper respiratory tract infection Neurology Dyskinesia Anesthesia Dopamine Agonists Female Neurology (clinical) Powders Geriatrics and Gerontology medicine.symptom business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Parkinsonism & Related Disorders. 81:144-150 |
| ISSN: | 1353-8020 |
| Popis: | Introduction CVT-301 (Inbrija®) 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 FEV1, FVC, and DLCO 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. |
| Databáze: | OpenAIRE |
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